Feasibility and safety of a robotic-assisted optical navigation system for pulmonary nodule percutaneous cryoablation: a prospective, single-center, single-arm pilot study

Feasibility and safety of a robotic-assisted optical navigation system for pulmonary nodule percutaneous cryoablation: a prospective, single-center, single-arm pilot study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Feasibility and safety of a robotic-assisted optical navigation system for pulmonary nodule percutaneous cryoablation: a prospective, single-center, single-arm pilot study Xiuping Wu, Weiyi Wan, Lianyue Yang, Xu Shi, Jielong Lin, Jiangyu Cui, and 7 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7395827/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Percutaneous cryoablation under imaging guidance is an effective therapeutic modality for pulmonary nodules, but the conventional technique relies on surgical complexity and physician experience. Computed tomography (CT)-guided robotic-assisted percutaneous puncture technique provides three-dimensional (3D) reconstruction, optimal needle trajectory planning, and monitoring of real-time respiratory motion, thereby enabling safe ablation of lung nodules. This study aimed to clinically evaluate the feasibility and safety of a robotic-assisted optical navigation system when utilized for CT-guided percutaneous cryoablation of pulmonary nodules. Methods Patients who underwent CT-guided percutaneous cryoablation via a robotic-assisted optical navigation system were prospectively enrolled in our study. The primary outcomes were the technical success rate and the technical efficacy rate, and the preoperative, intraoperative, and postoperative variables were recorded and analyzed for each patient. Results A total of 37 consecutive patients with a single nodule were ultimately enrolled in the present study. The technical success rate was 100%, and the technical efficacy rate of robotic-assisted cryoablation was 100% with no recurrence during the 1-month follow-up. The average number of needle adjustments per nodule was 0.82 ± 1.19 in this study, with a mean deviation of 3.47 ± 2.47 mm. The mean numbers of CT acquisitions and dose length products (DLPs) used during needle insertion were 3.44 ± 1.65 and 638.86 ± 434.44 mGy*cm, respectively. The duration of needle placement was 15.95 ± 5.06 min, whereas the total procedural duration was 99.32 ± 32.00 min. Notably, the deviation was found to be significantly correlated with the lobar location and was more prominent in the lower lobe. However, no significant correlations were observed with the nodule type, size, distance to the pleura, chest wall thickness, needle trajectory length, decubitus position, or the pulmonary function status of the patient. Moreover, no significant changes were found in the pulmonary function of the patients before or after the treatment. No major grade ≥ 3 complications were observed. However, among the minor complications, there were 5 cases (13.51%) of immediate pneumothorax, 2 cases (5.41%) of delayed pneumothorax, and 1 case (2.70%) of hemorrhage. Conclusion The robotic-assisted optical navigation system is feasible, safe and effective for CT-guided percutaneous cryoablation of pulmonary nodules. Robotic-assisted navigation system pulmonary nodule percutaneous cryoablation Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Introduction According to a 2022 global cancer statistics report, lung cancer is the most frequently diagnosed cancer worldwide, with a mortality rate of 18.7% and an incidence rate of 12.4% among all cancers [ 1 ]. While surgical resection is widely regarded as the standard of care for both primary and metastatic lung lesions, the development of image-guided ablative techniques has emerged as a valuable alternative, particularly for patients who may not be eligible for surgery due to pulmonary dysfunction, various comorbidities, or prior treatments, among other factors [ 2 , 3 ]. Currently, the commonly used percutaneous ablative procedures for lung lesions include radiofrequency ablation (RFA), microwave ablation (MWA), and cryoablation [ 4 – 6 ]. Unlike heat-based techniques such as RFA and MWA, cryoablation destroys lesion tissue by dehydrating tissue cells at ultra-low temperatures via liquid nitrogen or argon gas [ 7 ]. This process generates a visible 'ice ball' due to the freezing of lung tissue, which can be visualized on CT and used to estimate technical success and assess treatment efficacy [ 7 – 10 ]. Furthermore, compared with thermal ablation modalities, cryoablation involves low temperature, which allows for the preservation of collagenous architectures, offers a greater safety profile adjacent to critical structures, induces less pain during the procedure, and elicits a systemic immune response [ 8 – 18 ]. Previous multicenter clinical trials and large-scale studies have confirmed that cryoablation is safe and feasible and has favorable outcomes in terms of local tumor control and overall survival rates [ 10 , 14 , 19 – 22 ]. However, manual percutaneous puncture solely by an operator presents significant challenges because of the reliance on experience, the precision needed, and the complexity of human anatomy [ 23 , 24 ]. These factors necessitate multiple freehand needle manipulations until a satisfactory cryoprobe position is achieved, leading to a more time-consuming procedure, a higher incidence of complications, unnecessary radiation exposure, and even failure. In recent years, with the development of innovative technological advances, a series of robotic-assisted navigational systems have been developed to provide tailored solutions that simplify technically challenging procedures and reduce radiation exposure and complication rates [ 25 – 29 ]. Despite these advantages, the aforementioned robotic-assisted systems have limitations such as an inability to track patient movement and dynamic respiration in real-time, large space occupation, and special requirements for CT equipment. In response to these limitations, a novel robot-assisted optical navigation system has been developed, and previous clinical studies have demonstrated the safety, feasibility, accuracy, and generalizability of this system, enabling physicians to perform image-guided percutaneous puncture biopsy and preoperative localization for thoracic and abdominal lesions [ 23 , 30 , 31 ]. A case report of CT-guided percutaneous biopsy and cryoablation using this robotic system for subcentimeter pulmonary metastatic sarcoma also revealed the safety and feasibility of ablation treatment [ 32 ]. Considering the limitations of this case report, this prospective pilot study aims to further verify the feasibility and safety of the novel robotic-assisted navigation system in the clinical practice of cryoablation for lung lesions. Methods Patient Selection Participants who were candidates for robotically driven CT-guided cryoablation of pulmonary nodules at the First Affiliated Hospital of Guangzhou Medical University from 18 April 2024 to 28 May 2025 were enrolled in this study. The inclusion criteria were as follows: (i) aged ≥ 18 years, regardless of sex; (ii) patients with indications for percutaneous cryoablation as determined by the multidisciplinary team (MDT) panel, or nonsurgical candidates due to formidable lesion location, advanced age, or poor health status; and (iii) willing to participate in this study and provide informed consent. The exclusion criteria were as follows: (i) severe bleeding tendencies and coagulation disorders that cannot be improved in the short term; (ii) severe cachexia and cardiopulmonary insufficiency (e.g., severe pulmonary arterial hypertension); (iii) severe pulmonary emphysema, chronic obstructive pulmonary disease, or pulmonary fibrosis; (iv) the presence of a psychotic episode; (v) Eastern Cooperative Oncology Group (ECOG) performance status (PS) score > 3; and (vi) the use of anticoagulants, antiplatelet aggregation drugs, or antiangiogenic drugs that cannot be discontinued in the short term. This clinical study was approved by the Ethics Committee for Human Research of the First Affiliated Hospital of Guangzhou Medical University [EC-2024-026 (XJS)-02]. All procedures performed in the studies were in accordance with the 1975 Declaration of Helsinki (as revised in 2013), and written informed consent was obtained from all individual participants included in the study. Robotic-assisted Optical Navigation System The robotic-assisted optical navigation system (TH-S1, TrueHealth Medical Technology Co., Ltd., Hengqin, China), employed in this study and specifically engineered for interventional procedures, has obtained approval from the National Medical Products Administration (NMPA) as a class III medical device. It consists of three core components: an optical navigation system, a surgical planning system, and a robotic arm positioning and puncture system (Fig. 1 ). The optical navigation system is utilized to precisely track the actual position and orientation of the patients by detecting location trackers via a wireless technique. It also monitors dynamic respiration with a breathing curve displayed on the user interface, providing real-time feedback to indicate the optimal time for needle insertion. The surgical planning system enables the reconstruction of a visualized three-dimensional (3D) model encompassing pulmonary nodules, vessels, bronchi, bone structures, and skin. It facilitates the creation of a comprehensive needle insertion trajectory plan, as determined by physicians, and subsequently converts the optimal plan into the physical surgical environment. The robotic arm positioning and puncture system autonomously moves to the target position, following a predetermined trajectory with high precision while maintaining stable needle holding and guiding needle insertion. Preoperative imaging and 3D reconstruction On the day of the procedure, the physician, anesthetist, and radiologist collaborated to perform CT-guided robotic-assisted cryoablation with local or general anesthesia for nonsurgical candidates. The appropriate patient posture on the CT bed was determined according to the lesion location. Skin-adhering fixation devices were placed at the projected surface location of the lung lesion, after which the patient underwent the initial CT scan (NeuViz 128, Neusoft Medical Systems Co., Ltd., Shenyang, China, 120 kV, auto mAs, slice thickness 0.625 mm). During the cryoablation process, all the CT images were stored in DICOM format. The initial CT data were subsequently uploaded to a computer-assisted surgery system (Hisense, Qingdao, China) for comprehensive 3D reconstruction of anatomical structures, as mentioned above. Navigation planning and robotic-assisted percutaneous puncture The optical camera captured accurate spatial information of the nodule from the locator and automatically registered the 3D model with the actual body position of the patient via nodule coordinates derived from the CT images. The surgical planning module subsequently considers both the spatial location of the nodule and the respiratory motion curve of the patient to determine the optimal needle insertion trajectory while avoiding major blood vessels and other critical anatomical structures. The robotic arm stably guided the needle holder along the planned path to the designated surface location on the basis of predefined puncture points, angles, and depths. Following local infiltration anesthesia at the target site or general anesthesia, the operator inserted the cryoprobe under the guidance of the holder, with real-time needle depth displayed on the system interface. Once the cryoprobe was accurately positioned at the target, location the final ablation of the nodule was initiated. Cryoablation Procedure The platelet count, international normalized ratio, prothrombin time, and partial thromboplastin time were determined before the procedure. Cryoablation was performed by the same respiratory physician (Yanwei Chen), who has ove r 20 years of experience in pulmonary diagnosis and treatment, using a commercially available argon and helium gas-based VISUAL ICE Cryoablation System (Boston Scientific, Marlborough, MA, USA) with an number of 17-gauge cryoprobes. The distance between the edge of the nodule and that of the nearer cryoprobe was kept within 1 cm, whereas the distance between the 2 cryoprobes was < 1.5 cm. On the basis of lesion characteristics, three freezing-thawing cycles are commonly applied. Each cycle consisted of 5 minutes, 10 minutes, 10 minutes of freezing and 3 minutes interval of thawing. CT scans were acquired immediately after the procedure to assess the ablation zone and complications. The edge of the ice ball was 0.5 cm larger than the edge of the lesion to ensure that the nodule was thoroughly ablated, thereby achieving satisfactory clinical outcomes. Pulmonary Function Evaluation Pulmonary function tests were conducted by the same respiratory lab technicians in the First Affiliated Hospital of Guangzhou Medical University with a MasterScreen pulmonary function test system (Jeager) according to the guidelines of the American Thoracic Society (ATS). The forced expiratory volume in the first second (FEV 1 ), percent to the predictive value of FEV 1 (FEV 1 % predicted), forced vital capacity (FVC), percent to the predictive value of FVC (FVC% predicted), FEV 1 -to-FVC ratio (FEV 1 /FVC%), percent to the predictive value of FEV 1 /FVC% (FEV 1 /FVC% predicted), and percent to the predictive value maximal mid-expiratory flow percentage (MMEF% predicted) were recorded from the pulmonary function test before and after CT-guided robotic-assisted cryoablation treatment. All patients underwent pulmonary function testing three times, and the optimal value was recorded. Follow-up Follow-up chest radiographs and contrast CT scans performed the following day were aimed at evaluating the detection of the adverse events and the technical efficacy rate. Follow-up dynamic CT chest scans of patients were carried out at 1 week, 1 month, and at 3 month intervals. In this study, evaluation of local control or prognosis was not conducted due to the short postoperative follow-up duration. Cumulative sum (CUSUM) Learning Curve Analysis The learning curve evaluation adopted the CUSUM method with the cusum (v0.4.1) R package, which visualizes patterns in the data by converting raw data into an accumulation of deviations from the average value [ 33 , 34 ]. Patients with a single lesion were categorized in chronological order, and the duration of needle placement (performed by the same physician) was recorded to calculate the CUSUM value as follows: where \(\:{P}_{i}\) and \(\:\stackrel{-}{P}\) indicate the individual puncture time and the mean puncture time, respectively. Data collection and definition Preoperative data for each patient and nodule, including age, sex, smoking history, ECOG PS, BMI, pulmonary function, pulmonary background disease, maximum diameter, location, type, and rib obstruction status, were systematically collected. Intraoperative data included decubitus position, chest wall thickness, distance between the pleura and nodule, needle trajectory length, out-of-plane puncture, technical success rate, number of needle adjustments, deviation, time, CT scans, DLPs for needle insertion, and total procedural duration. Technical success was defined as completing the procedure via robotic guidance without major system deficiencies, robotic arm collisions, or significant manual needle adjustments [ 35 ]. The number of needle adjustments was counted from the initial insertion to the final confirmation of reaching the target nodule. The deviation was calculated as the distance from the needle tip position to the nodule center. The number of CT scans each patient underwent was recorded from the initial CT scan for 3D reconstruction and trajectory planning to the validation CT scan of proper needle placement, as well as the DLP calculation. The duration of needle placement was determined by the difference between the two timestamps of the initial CT scan and the validation CT scan, as mentioned above. The total procedural duration was defined as the time from the initial preoperative CT scan to the final CT scan after the cryoablation procedures. Postoperative data included the technical efficacy rate and the postoperative complications. The technical efficacy of cryoablation was demonstrated by the complete ablation of the target nodule, with evidence obtained from imaging immediately following the last ablation procedure and follow-up imaging at 1, 3, 6, 9, and 12 months after treatment [ 36 ]. Puncture-related complications, including minor (grades 1–2) and major complications (grades 3–4), were classified according to the adverse event classification from the Society of Interventional Radiology (SIR) Standards of Practice Committee [ 37 ]. Statistical analysis All the statistical analyses were performed using R 4.2.2. Patient and nodule characteristics were summarized via means with standard deviations or medians with ranges for continuous variables. Categorical variables were presented as numbers with percentages. For comparisons of exploratory analyses between two groups or among multiple groups, the Mann-Whitney U test and Kruskal-Wallis test were used, respectively, for the continuous variables. Notably, the pre- and postoperative changes in pulmonary function parameters were assessed using the paired Wilcoxon signed-rank test. The Spearman rank correlation test was used to evaluate correlations between variables, with the corresponding Spearman correlation coefficient (R Spearman ) reported. The Jonckheere-Terpstra trend test for the continuous variables was used to validate the CUSUM learning curve analysis. Statistical significance was set at a P -value of less than 0.05. Results Patient and Nodule Baseline Characteristics From April 18, 2024, to May 28, 2025, a total of 50 consecutive patients were prospectively enrolled and underwent initial screening. After excluding those with multiple lesions, lesion sizes exceeding 3 cm, or procedures not performed as planned according to the protocol, 37 patients with single nodules were ultimately included in the study (Fig. 2 ). Among these patients, 20 (54.05%) were female, and 23 (62.16%) had no smoking history. The median age was 60 years (range: 35 to 77 years), with a mean body mass index (BMI) of 22.81 ± 3.04 kg/m² (range: 15.40 to 29.88 kg/m²). Additionally, 36 (97.30%) patients had an Eastern Cooperative Oncology Group performance status (ECOG PS) score of ≤ 1. Of the 37 patients, 12 (32.43%) underwent cryoablation alone with the assistance of the TH-S1 system, while 25 (67.57%) underwent cryoablation in combination with biopsy. With respect to baseline pulmonary function, the average FEV 1 was 2.08 ± 0.86 L (range: 0.56 to 4.13 L), the average FVC was 2.95 ± 0.81 L (range: 1.29 to 5.00 L), the average FEV 1 /FVC% was 69.15% ± 17.70% (range: 25.13–87.20%), and the average MMEF% predicted was 52.12% ± 28.24% (range: 6.21–106.27%). Meanwhile, 9 (24.32%) patients were previously diagnosed with pulmonary background diseases associated with emphysema (Table 1 ). Table 1 Clinical characteristics of the patients. Characteristics (n = 37) Age (years) 60.00 [35.00, 77.00] Gender (n,%) Female 20 (54.05%) Male 17 (45.95%) Smoking (n,%) Yes 14 (37.84%) No 23 (62.16%) ECOG PS (n,%) 0 28 (75.68%) 1 8 (21.62%) 2 1 (2.70%) BMI (kg/m 2 ) 22.81 ± 3.04 [15.40, 29.88] FEV1 (L)* 2.08 ± 0.86 [0.56, 4.13] FVC (L)* 2.95 ± 0.81 [1.29, 5.00] FEV1/FVC (%)* 69.15 ± 17.70 [25.13, 87.20] MMEF75/25 (L/s)* 52.12 ± 28.24 [6.21, 106.27] Emphysema (n,%) Yes 9 (24.32%) No 28 (75.68%) Percutaneous procedure (n,%) Cryoablation 12 (32.43%) Biopsy and cryoablation 25 (67.57%) Characteristics are expressed as median [range], mean ± standard deviation [range], or number (%). * indicated that nine patients who did not have the pulmonary function results were excluded. ECOG PS, Eastern Cooperative Oncology Group performance status; BMI, body mass index; FEV1, forced expiratory volume in the first second; FVC, forced vital capacity; MMEF, maximal mid-expiratory flow curve. For nodule characteristics, the nodules were categorized as pure ground-glass nodules (GGNs) [8 (21.62%)], mixed GGNs [7 (18.92%)], and solid nodules [22 (59.46%)]. The distribution of nodules across the lung lobes was as follows: 8 (21.62%) in the left lower lobe (LLL), 10 (27.03%) in the left upper lobe (LUL), 9 (24.32%) in the right lower lobe (RLL), 8 (21.62%) in the right upper lobe (RUL), and 2 (5.41%) in the right middle lobe (RML). The average maximum diameter of target nodules was 13.81 ± 6.42 mm (range: 3.00 to 30.00 mm), with rib obstruction noted in 3 (8.11%) of the nodules, indicating the challenging nature of needle insertion (Table 2 ). Table 2 Clinical characteristics of the nodules. Characteristics Nodule maximum diameter (mm) 13.81 ± 6.42 [3.00, 30.00] Lobar location (n,%) LLL 8 (21.62%) LUL 10 (27.03%) RLL 9 (24.32%) RML 2 (5.41%) RUL 8 (21.62%) Nodule types (n,%) Mixed GGN 7 (18.92%) Pure GGN 8 (21.62%) Solid 22 (59.46%) Rib obstruction (n,%) Yes 3 (8.11%) No 34 (91.89%) Pathology (n,%) # Adenocarcinoma 19 (51.35%) Squamous cell carcinoma 3 (8.11%) Metastasis 1 (2.70%) Atypical adenomatous hyperplasia 4 (10.81%) Inflammation or infection 6 (16.22%) Characteristics are expressed as mean ± standard deviation [range] or number (%). # indicated that four patients who did not have the histopathology results were excluded. LLL, left lower lobe; LUL, left upper lobe; RLL, right lower lobe; RML, right middle lobe; RUL, right upper lobe; GGN, ground-glass nodule. In terms of pathological diagnosis, among all patients, 19 (51.35%) had adenocarcinoma, 3 (8.11%) had squamous cell carcinoma, 1 (2.70%) had malignant metastasis, 4 (10.81%) had atypical adenomatous hyperplasia, and 6 (16.22%) had inflammation or infection (Table 2 ). Technical characteristics and outcomes of robotic-assisted cryoablation procedures All procedures were performed successfully using the TH-S1 system, with 14 (37.84%) patients in the supine puncture position, 8 (21.62%) in the lateral position, and 15 (40.5%) in the prone position. The total needle trajectory length, chest wall thickness, and distance to the pleura were 62.66 ± 15.87 mm (range: 34.70 to 94.80 mm), 37.60 ± 11.05 mm (range: 18.70 to 63.60 mm), and 23.92 ± 12.92 mm (range: 8.00 to 61.00 mm), respectively. Specifically, a total of 14 (37.84%) nodules underwent out-of-plane punctures in the present study. Two successful robotic-assisted cryoablation procedures with a high level of difficulty are illustrated in Fig. 3 and Fig. 4 . During the procedures, the average number of needle adjustments was 0.82 ± 1.19 (range: 0.00 to 5.00), with a mean deviation of 3.47 ± 2.47 mm (range: 0.00 to 10.00 mm). Moreover, the average number of CT scans was 3.44 ± 1.65 (range: 2.00 to 8.00), with an average DLP of 638.86 ± 434.44 mGy*cm (range: 260.06 to 2239.42 mGy*cm). The mean duration of needle placement was 15.95 ± 5.06 min (range: 9.00 to 38.00 min), whereas the total procedural duration was 99.32 ± 32.00 min (range: 55.00 to 166.00 min). Notably, the deviation was found to be significantly correlated with the lobar location, which was more prominent in the lower lobe ( p = 0.013), but no significant correlation was observed with the nodule type ( p = 0.640), size ( p = 0.477), distance to the pleura ( p = 0.491), chest wall thickness ( p = 0.241), needle trajectory length ( p = 0.179), decubitus position ( p = 0.499), or pulmonary function status of the patient ( p = 0.398 for the presence or absence of emphysema, p = 0.901 for different pulmonary function statuses) (Figure S1 and S2). During the postoperative observations, no severe complications occurred, while 8 (21.62%) cases experienced minor complications, including 5 (13.51%) cases of immediate pneumothorax, 2 (5.41%) cases of delayed pneumothorax, and 1 (2.70%) case of hemorrhage. Furthermore, the median duration of follow-up was 39 days. After excluding cases with missing or incomplete follow-up data, the complete ablation zone coverage on intraoperative images and the 1-month imaging follow-up confirmed a 100% technical efficacy rate for robotic-assisted cryoablation. Table 3 summarizes the intraoperative and postoperative technical characteristics and outcomes. Table 3 Technical characteristics and outcomes of robotic-assisted cryoablation procedures. Variables (n = 37) Decubitus position (n,%) Lateral 8 (21.62%) Prone 15 (40.54%) Supine 14 (37.84%) Out of Plane (n,%) Yes 14 (37.84%) No 23 (62.16%) Chest wall thickness (mm) 37.60 ± 11.05 [18.70, 63.60] Distance from the pleural surface (mm) 23.92 ± 12.92 [8.00, 61.00] Needle trajectory length (mm) 62.66 ± 15.87 [34.70, 94.80] Anesthesia (n,%) Local 8 (21.62%) General 29 (78.38%) Technical success rate (n, %) 37 (100%) Number of needle adjustment (mm) 0.82 ± 1.19 [0.00, 5.00] Deviation (mm) 3.47 ± 2.47 [0.00, 10.00] Duration needle placement (min) 15.95 ± 5.06 [9.00, 38.00] Number of CT scans for needle insertion 3.44 ± 1.65 [2.00, 8.00] DLPs during needle insertion (mGy·cm)* 638.86 ± 434.44 [260.06, 2239.42] Intraoperative complications No Total procedural duration (min) 99.32 ± 32.00 [55.00, 166.00] Technical efficacy rate (%) # 35 (100%) Complications (n,%) Major complications (grade 3–4) No Minor complications (grade 1–2) 8 (21.62%) Immediate pneumothorax 5 (13.51%) Delayed pneumothorax 2 (5.41%) Hemorrhage 1 (2.70%) Characteristics are expressed as mean ± standard deviation [range] or number (%). * indicated that one patient missing the result of the DLPs during needle insertion was excluded. # indicated that two patients missing the follow-up data were excluded. CT, computed tomography; DLPs, dose length products. To evaluate the clinical minimally invasive nature and patient tolerance of the robotic-assisted cryoablation technique, serial pulmonary function evaluations were conducted in 11 patients whose baseline and postoperative pulmonary function data were available. Among these patients, the mean baseline values for FEV 1 , FVC, FEV 1 /FVC%, and MMEF% predicted were 2.48 ± 0.96 L (range: 0.88 to 4.13 L), 3.53 ± 1.06 L (range: 1.29 to 5.00 L), 74.03% ± 13.67% (range: 37.00–86.00%), and 59.03% ± 27.62% (range: 10.69–106.27%), respectively. Postoperatively, the corresponding values were 2.49 ± 0.94 (range: 0.86 to 4.10), 3.32 ± 1.06 (range: 1.24 to 5.07), 75.42% ± 14.69% (range: 33.00–85.00%), and 65.80% ± 22.74% (range: 17.83–90.00%). As expected, there were no significant changes in the pulmonary function between the baseline and postoperative periods on the basis of the above parameters and their percentage of predicted values (Fig. 5 , Figure S3). Learning Curve Evaluation The duration of needle placement for each TH-S1 procedure was systematically recorded to facilitate the calculation of CUSUM values and subsequent validation analyses (Fig. 6 ). A total of 35 patients were enrolled in the final learning curve evaluation because two patients had a distinct intraoperative needle planning procedure compared with the other patients. As shown in Fig. 6 A, two pivotal cutoff points were identified at the 5th and 13th cases, thereby partitioning the learning curve into three distinct phases: Phase I (the initial 5 cases), Phase II (cases 6th to 13th ), and Phase III (after the 13th case). In Phase I, the duration of needle placement surpassed the average, and the learning curve showed a steep upward trend, corresponding to a significant increase in needle insertion time. In Phase II, the duration of needle placement remained above average, with the learning curve exhibiting a gradually increasing trend, indicating a decelerated rate of improvement compared with the initial phase. Upon reaching the 13th case, the duration of needle placement transitioned to falling below the average and maintained a consistent downward trend throughout Phase III. Further validation analyses confirmed a statistically significant reduction in the duration of needle placement, deviation, and associated number of CT scans across the three phases (Fig. 6 B). Disscussion In recent years, percutaneous cryoablation under CT guidance has been proven to be a safe and effective treatment modality for inoperable patients with pulmonary nodules [ 7 , 8 , 10 , 13 , 22 , 38 ]. As a percutaneous puncture procedure, it depends on achieving conformal needle placement and precise puncture of therapeutic devices. Conversely, inaccurate localization may require repeated puncture attempts and multiple CT scans, resulting in longer procedural duration, potential radiation exposure, and increased risk of complications for the patient. As positioning navigation and robotic technologies have advanced, new tools and solutions have become available for overcoming the aforementioned problems [ 23 , 25 – 31 ]. This study utilized a novel robotic-assisted optical navigation system, the TH-S1, to achieve minimally invasive percutaneous cryoablation during CT-guided procedures. This technique demonstrated high feasibility and safety for treating pulmonary nodules, with high technical success and efficacy rates. Navigation and robotic systems aim to improve the accuracy and efficiency of percutaneous image-guided interventions, and the autonomy and integration of advanced imaging and artificial intelligence (AI) may reflect their potential [ 39 ]. Currently, autonomy is continuously being improved toward incorporating planning, navigation, and assessment software, including image fusion, automated lesion segmentation, real-time tracking of needle trajectories, margin confirmation, heatmaps, or postoperative assessment [ 40 ]. In a recent study, Cornelis et al. [ 39 ] evaluated the autonomy of navigation and robotic systems for percutaneous image-guided interventions via an aggregate score consisting of the levels of autonomy in surgical robotics (LASR) classification system and the levels of integration of advanced imaging and AI (LIAI2) classification system. The LASR classification system ranges from no autonomy (0) to full autonomy (5). Similarly, the LIAI2 classification system ranges from independent imaging (0) to autonomous navigation (5). Despite currently available systems representing task-specific machines with limited functionality and not rising to the level of true robots, the Epione (Quantum) system [ 35 , 41 ], which achieved the highest aggregate scores (1 for robot assistance and 3 for automated assistance), epitomizes the most advanced stage of the percutaneous image-guided interventional field in this report. This is similar to the TH-S1 system used in our research. The TH-S1 system offers several unique features: visualized 3D reconstruction of various anatomical components, real-time tracking of patient position and orientation, comprehensive trajectory planning, continuous recording of respiratory motion, and stable needle holding with guided insertion. These functions enhance the efficiency, accuracy, and safety of interventional planning and performance, resulting in a higher first-pass success rate in contrast to the conventional freehand stepwise needle advancement technique. Previous studies in the literature have addressed the efficacy and safety of the TH-S1 system for CT-guided percutaneous preoperative localization, percutaneous transthoracic needle biopsy (PTNB), and thermoablation. Duan et al. [ 42 ] evaluated the robotic-assisted percutaneous localization technique for peripheral pulmonary nodules in the swine lung through fluorescent agent injection, reporting the mean deviation by measuring the 3D distance of 3.81 ± 1.29 mm, with a surprising first-attempt success rate of 100% and a mean localization time of 14.69 ± 4.67 min. As an animal experiment, deeper nodules under the pleural surface or the capability of tracking and compensating for patient respiratory motion were not considered. Thus, Liu et al. [ 31 ] investigated the accuracy and safety of the same technique in clinical applications, still achieving a first-pass success rate of 100%, with a median deviation of 6.1 mm and a median localization time of 25.0 min, demonstrating satisfactory accuracy and holding promise for improving the percutaneous localization of lung nodules. Jing et al. [ 23 ] conducted a prospective clinical study evaluating the TH-S1 system for percutaneous puncture of CT-guided thoracic and abdominal lesions, including biopsy and thermoablation. Compared with a control group punctured manually, the system demonstrated remarkable performance, with a considerably higher once-puncture success rate of 100% and a reduced number of CT scans averaging 3.03 ± 0.18 times. Another real-world clinical study evaluated the feasibility and safety of the TH-S1 system for PTNB compared with the conventional freehand technique and assessed its generalizability across operators of different experience levels [ 30 ]. The robot-assisted navigation system could decrease the number of punctures, number of CT scans, and incidence of adverse events such as pneumothorax. This approach also reduces the influence of operator experience on PTNB and enhances its clinical applicability. Despite the growing utilization of this system in CT-guided interventions for lung nodules, sufficient evidence regarding its clinical value in lung cryoablation remains to be determined. Moreover, given that no clinical investigations on robotic-assisted percutaneous cryoablation have been reported to date, and that previous research on conventional free-hand percutaneous puncture has focused mainly on dynamic pulmonary function changes, adverse events, treatment efficacy, and influence on immunologic mechanisms [ 13 , 22 , 38 , 43 ], this prospective study was performed to further evaluate the clinical value of the robotic-assisted navigation system. In the present study, the prospective cohort consisted of patients with pulmonary nodules of various sizes, lung lobar locations, lesion types, distance to the pleura, and decubitus position to demonstrate the generalizability of the findings to various lesion settings and the system's capacity to guide punctures in different clinical practices. Consistent with prior findings, the respiratory-induced motion amplitude of nodules is greater in the lower lobes, resulting in inaccurate localization during the CT-guided percutaneous lung puncture [ 44 ]. Nevertheless, owing to the lack of control group data on deviations of nodules in different lobar locations, we are unable to determine whether the robotic-assisted puncture technique confers any benefits to nodules located in the lower lobes during the puncture procedure. In addition, the accuracy of the robotic-assisted cryoablation was not affected by the nodule type, the maximum diameter of the nodule, the distance to the pleura, or the decubitus position, a finding similar to that reported in a previous study [ 31 ]. Few studies have investigated the learning process of CT-guided interventional radiology under robotic assistance [ 34 ]. Although the sample size of this pilot study was limited, CUSUM analysis was performed as an exploratory analysis and suggested that the learning curve of robotic-assisted CT-guided percutaneous cryoablation for pulmonary nodules comprised three distinct phases. These phases of the learning curve were identified by two cutoff points (case 5 and case 13), at which the inclination and trend of the curves sharply changed. As previously mentioned, the CUSUM curve reflects sequential changes relative to an average value. Thus, the two cutoff points on the CUSUM curve represent two critical points in the learning process regarding the duration of needle placement. In this study, first, Phase I, as the initial learning period, involved gradually acquiring technical competence and skills to significantly reduce the puncture time (cases 1 to 5). Second, Phase II, as the consolidation period, could be interpreted as the accumulation of additional experience after the initial learning curve and as the consolidation of the experience gained during the first phase (cases 6 to 13). Finally, Phase III represented the mastery period, suggesting the acquisition of a greater competence in the execution of this preoperative localization procedure under robotic guidance (cases 14 to 35). Furthermore, as expected, the duration of needle placement, deviation, and number of CT scans significantly decreased across the three distinct phases. Additionally, these findings could help less experienced physicians accurately understand the benefits of using a robotic-assisted optical navigation system in CT-guided percutaneous interventional procedures. In other words, one of the major advantages of the robotic-assisted navigation system is that it can reduce adverse effects from the first-time use of new technology [ 30 ]. Consequently, all procedures were performed successfully, resulting in a notable technical success rate of 100% and a 100% technical efficacy rate, as evidenced by intraoperative and 1-month follow-up imaging, indicating the feasibility and effectiveness of the TH-S1 system in clinical practice. During the postoperative observation, no major complications were reported; eight minor complications occurred, including five cases of immediate pneumothorax, two cases of delayed pneumothorax, and one case of hemorrhage, indicating the safety of the TH-S1 system. Delayed pneumothorax is classified as a relatively rare complication, defined as a pneumothorax occurring as early as 4 hours after the procedure [ 45 ]. A previous study has demonstrated that a history of multiple punctures in small lesions located in the upper lobes is associated with an increased risk of delayed pneumothorax development, which is consistent with the condition observed in our two patients, whose lesions were both located in the right upper lobe of the lung [ 46 ]. Regarding lesions in upper lobes as a risk factor of delayed pneumothorax, a reasonable explanation is that pulmonary air in the upper lobes with less movement may escape slowly, resulting in late appearance of pneumothorax. Conversely, lesions involving lower lobes with greater mobility and higher aeration may result in early appearance of pneumothorax. Moreover, the osmotic effects of cryoablation, which induce vasoconstriction and thereby diminish blood flow to the treated tissue, may also aid in reducing intraoperative bleeding [ 47 ]. The bleeding risk can be mitigated by avoiding the puncture of large vessels, or by using active thawing at the end of the procedure to avoid cracks in the ice. Nevertheless, among these patients, all patients improved following rest, oxygen therapy, conservative treatment, and intensive clinical monitoring. The present study has several limitations that should be acknowledged. First, this was a single-center study with a small sample size, which limits the generalizability of our findings. Second, the lack of a freehand control group makes it difficult to accurately determine the superiority attributed to the TH-S1 system. At present, both in China and internationally, only a limited number of clinical centers have implemented robotic-assisted percutaneous cryoablation. Nevertheless, our findings provide valuable insights and references for the clinical promotion of this technology. Further large-scale randomized studies are warranted to offer a more comprehensive evaluation of the currently available CT-guided robotic-assisted optical navigation system. Conclusion In conclusion, CT-guided percutaneous cryoablation assisted by the TH-S1 system is safe, feasible, minimally invasive, and highly accurate for treating pulmonary nodules, particularly in patients for whom surgery is contraindicated. The TH-S1 system has the potential to serve as a valuable auxiliary tool for CT-guided lung interventions in clinical practice. Declarations Acknowledgments All the authors substantially contributed to the conception of the work and approved the final version of the manuscript. Clinical trial number Not applicable. Funding This work was financially supported by the National Natural Science Foundation of China (82070096). Statement of Ethics This study protocol was reviewed and approved by the Ethics Committee for Human Research of the First Affiliated Hospital of Guangzhou Medical University [EC-2024-026 (XJS)-02]. All procedures performed in the studies were in accordance with the 1975 Declaration of Helsinki (as revised in 2013), and written informed consent was obtained from all individual participants included in the study. Conflict of Interest Statement The authors have no conflicts of interest to declare. Author Contributions All the authors meet the criteria for authorship recommended by the International Committee of Medical Journal Editors and critically revised the manuscript for important intellectual content. 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10:58:02","extension":"png","order_by":19,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":1273,"visible":true,"origin":"","legend":"","description":"","filename":"Onlinefloatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-7395827/v1/401deabdff2461d0b1748a7a.png"},{"id":92499268,"identity":"6c239fa4-af25-4edd-8a32-a7ec4455585b","added_by":"auto","created_at":"2025-09-30 10:58:02","extension":"xml","order_by":20,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":142753,"visible":true,"origin":"","legend":"","description":"","filename":"618b091e9d9643888914d34432fe60181structuring.xml","url":"https://assets-eu.researchsquare.com/files/rs-7395827/v1/fafbbf5c1933633747206eac.xml"},{"id":92499270,"identity":"1d5702e0-25b4-4b33-90d4-582815385562","added_by":"auto","created_at":"2025-09-30 10:58:02","extension":"html","order_by":21,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":154682,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-7395827/v1/7d676419bbd824231132884a.html"},{"id":92499243,"identity":"41e5cff1-d6ca-48e1-ba1d-0add3a48b0f4","added_by":"auto","created_at":"2025-09-30 10:58:02","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":1141710,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eRobotic-assisted optical navigation system.\u003c/strong\u003e The optical navigation system allowed for precise tracking of the position of the patient and the robotic arm (I). The surgical planning system was used to reconstruct a three-dimensional model and plan the needle insertion trajectory (II). The robotic arm positioning and puncture system was employed for stable needle-holding and guiding needle insertion (III).\u003c/p\u003e","description":"","filename":"image2.png","url":"https://assets-eu.researchsquare.com/files/rs-7395827/v1/c13ac761e2ae3ce7cc5cd8a1.png"},{"id":92499245,"identity":"998a8a58-197e-4d1d-ba48-97e401925375","added_by":"auto","created_at":"2025-09-30 10:58:02","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":205332,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eFlowchart of the study participants.\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"image3.png","url":"https://assets-eu.researchsquare.com/files/rs-7395827/v1/b20f0b28138f46bffc864d88.png"},{"id":92499501,"identity":"36ecc112-92b1-4713-8a7d-37b0000a5d28","added_by":"auto","created_at":"2025-09-30 11:06:02","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":902552,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eSuccessful robotic-assisted cryoablation of a challenging nodule in a 62-year-old male patient.\u003c/strong\u003e (A) Initial CT image showing a pulmonary nodule, approximately 20 mm in size, in the right upper lobe that was obscured by the rib. (B) 3D reconstruction of the thoracic structure. (C) Needle trajectory planning based on the initial CT scan (axia\u003cu\u003el\u003c/u\u003e view). (D) Needle trajectory planning based on the initial CT scan (sagittal view). (E) Motion planning and simulation of the robotic arm to ensure avoidance of any obstructions during the procedure. (F) Intraprocedure image showing the cryoprobe inside the lesion during ablation procedure with no complications. (G) Postprocedure image showing an ice ball of sufficient size that completely ablated the nodule without immediate complications. (H) Postoperative day 1 imaging was performed to verify that no delayed complications occurred. (I) 1-month follow-up image showing scar formation in the ablation zone without recurrence.\u003c/p\u003e","description":"","filename":"image4.png","url":"https://assets-eu.researchsquare.com/files/rs-7395827/v1/279880f064d95dce3cd88f55.png"},{"id":92499502,"identity":"cbf55ec9-ba96-4a0b-9977-0146350aec69","added_by":"auto","created_at":"2025-09-30 11:06:02","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":897393,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eSuccessful robotic-assisted cryoablation of a challenging nodule in a 35-year-old female patient.\u003c/strong\u003e (A) Initial CT revealed a small pulmonary nodule, approximately 9 mm in size, in the right lower lobe, with a greater respiratory-induced motion amplitude. (B) 3D reconstruction of the thoracic structure. (C) Axial view of needle trajectory planning based on the initial CT scan. (D) Motion planning and simulation of the robotic arm to ensure the avoidance of any obstructions during the procedure. (E) Intra-procedure imaging to confirm needle placement. (F) Intraprocedure image showing the cryoprobe inside the lesion during the ablation procedure with no complications. (G) Postprocedure image showing an ice ball of sufficient size that completely ablated the nodule without immediate complications. (H) Postoperative day 2 imaging was performed to verify that no delayed complications occurred. (I) 1-month follow-up image showing scar formation in the ablation zone without recurrence.\u003c/p\u003e","description":"","filename":"image5.png","url":"https://assets-eu.researchsquare.com/files/rs-7395827/v1/1cc8035bde3115fd86620d90.png"},{"id":92499247,"identity":"74657e83-2f40-417d-9633-6dec5bb5be47","added_by":"auto","created_at":"2025-09-30 10:58:02","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":133817,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eDynamic changes in pulmonary function between the baseline and postoperative periods following robotic-assisted cryoablation.\u003c/strong\u003e (A) Forced expiratory volume in the first second (FEV\u003csub\u003e1\u003c/sub\u003e). (B) Forced vital capacity (FVC). (C) FEV\u003csub\u003e1\u003c/sub\u003e to FVC ratio (FEV\u003csub\u003e1\u003c/sub\u003e/FVC%). (D) Maximal mid-expiratory flow as a percentage of the predicted flow (MMEF% predicted).\u003c/p\u003e","description":"","filename":"image6.png","url":"https://assets-eu.researchsquare.com/files/rs-7395827/v1/5eb45eda2fd05bde0e6ee96f.png"},{"id":92500213,"identity":"2f07f487-b37c-4b27-b2c2-5bc7ea138c4c","added_by":"auto","created_at":"2025-09-30 11:14:02","extension":"png","order_by":6,"title":"Figure 6","display":"","copyAsset":false,"role":"figure","size":128500,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eLearning curve evaluation. \u003c/strong\u003e(A) CUSUM curve of duration of needle placement. As shown, two cutoff points at the 5\u003csup\u003eth\u003c/sup\u003e and 13\u003csup\u003eth\u003c/sup\u003e cases divide the learning curve into three phases: Phase I (the initial 5 cases), Phase II (cases 6\u003csup\u003eth\u003c/sup\u003e to 13\u003csup\u003eth\u003c/sup\u003e), and Phase III (after the 13\u003csup\u003eth\u003c/sup\u003e case). (B) Validation analyses of deviation, duration of needle placement, and number of CT scans across the three phases on the basis of the CUSUM learning curve.\u003c/p\u003e","description":"","filename":"image7.png","url":"https://assets-eu.researchsquare.com/files/rs-7395827/v1/1bdfc26e1db23b55f88cdc78.png"},{"id":93110781,"identity":"a25ce69a-f70f-43c3-98f8-4122007eb206","added_by":"auto","created_at":"2025-10-09 07:40:11","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":4882254,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7395827/v1/18586e65-a517-4f75-9c3f-953c5d166afb.pdf"},{"id":92501556,"identity":"a8e15139-6bf3-4736-9fca-d88b148f11b2","added_by":"auto","created_at":"2025-09-30 11:32:05","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":541043,"visible":true,"origin":"","legend":"","description":"","filename":"SupplementaryFigures.docx","url":"https://assets-eu.researchsquare.com/files/rs-7395827/v1/1436491305d9cd4aa9fe21dc.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Feasibility and safety of a robotic-assisted optical navigation system for pulmonary nodule percutaneous cryoablation: a prospective, single-center, single-arm pilot study","fulltext":[{"header":"Introduction","content":"\u003cp\u003eAccording to a 2022 global cancer statistics report, lung cancer is the most frequently diagnosed cancer worldwide, with a mortality rate of 18.7% and an incidence rate of 12.4% among all cancers [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. While surgical resection is widely regarded as the standard of care for both primary and metastatic lung lesions, the development of image-guided ablative techniques has emerged as a valuable alternative, particularly for patients who may not be eligible for surgery due to pulmonary dysfunction, various comorbidities, or prior treatments, among other factors [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eCurrently, the commonly used percutaneous ablative procedures for lung lesions include radiofrequency ablation (RFA), microwave ablation (MWA), and cryoablation [\u003cspan additionalcitationids=\"CR5\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Unlike heat-based techniques such as RFA and MWA, cryoablation destroys lesion tissue by dehydrating tissue cells at ultra-low temperatures via liquid nitrogen or argon gas [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. This process generates a visible 'ice ball' due to the freezing of lung tissue, which can be visualized on CT and used to estimate technical success and assess treatment efficacy [\u003cspan additionalcitationids=\"CR8 CR9\" citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Furthermore, compared with thermal ablation modalities, cryoablation involves low temperature, which allows for the preservation of collagenous architectures, offers a greater safety profile adjacent to critical structures, induces less pain during the procedure, and elicits a systemic immune response [\u003cspan additionalcitationids=\"CR9 CR10 CR11 CR12 CR13 CR14 CR15 CR16 CR17\" citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. Previous multicenter clinical trials and large-scale studies have confirmed that cryoablation is safe and feasible and has favorable outcomes in terms of local tumor control and overall survival rates [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan additionalcitationids=\"CR20 CR21\" citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. However, manual percutaneous puncture solely by an operator presents significant challenges because of the reliance on experience, the precision needed, and the complexity of human anatomy [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e, \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. These factors necessitate multiple freehand needle manipulations until a satisfactory cryoprobe position is achieved, leading to a more time-consuming procedure, a higher incidence of complications, unnecessary radiation exposure, and even failure.\u003c/p\u003e\u003cp\u003eIn recent years, with the development of innovative technological advances, a series of robotic-assisted navigational systems have been developed to provide tailored solutions that simplify technically challenging procedures and reduce radiation exposure and complication rates [\u003cspan additionalcitationids=\"CR26 CR27 CR28\" citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. Despite these advantages, the aforementioned robotic-assisted systems have limitations such as an inability to track patient movement and dynamic respiration in real-time, large space occupation, and special requirements for CT equipment. In response to these limitations, a novel robot-assisted optical navigation system has been developed, and previous clinical studies have demonstrated the safety, feasibility, accuracy, and generalizability of this system, enabling physicians to perform image-guided percutaneous puncture biopsy and preoperative localization for thoracic and abdominal lesions [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e, \u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e, \u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e]. A case report of CT-guided percutaneous biopsy and cryoablation using this robotic system for subcentimeter pulmonary metastatic sarcoma also revealed the safety and feasibility of ablation treatment [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e]. Considering the limitations of this case report, this prospective pilot study aims to further verify the feasibility and safety of the novel robotic-assisted navigation system in the clinical practice of cryoablation for lung lesions.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\n \u003ch2\u003ePatient Selection\u003c/h2\u003e\n \u003cp\u003eParticipants who were candidates for robotically driven CT-guided cryoablation of pulmonary nodules at the First Affiliated Hospital of Guangzhou Medical University from 18 April 2024 to 28 May 2025 were enrolled in this study. The inclusion criteria were as follows: (i) aged\u0026thinsp;\u0026ge;\u0026thinsp;18 years, regardless of sex; (ii) patients with indications for percutaneous cryoablation as determined by the multidisciplinary team (MDT) panel, or nonsurgical candidates due to formidable lesion location, advanced age, or poor health status; and (iii) willing to participate in this study and provide informed consent. The exclusion criteria were as follows: (i) severe bleeding tendencies and coagulation disorders that cannot be improved in the short term; (ii) severe cachexia and cardiopulmonary insufficiency (e.g., severe pulmonary arterial hypertension); (iii) severe pulmonary emphysema, chronic obstructive pulmonary disease, or pulmonary fibrosis; (iv) the presence of a psychotic episode; (v) Eastern Cooperative Oncology Group (ECOG) performance status (PS) score\u0026thinsp;\u0026gt;\u0026thinsp;3; and (vi) the use of anticoagulants, antiplatelet aggregation drugs, or antiangiogenic drugs that cannot be discontinued in the short term.\u003c/p\u003e\n \u003cp\u003eThis clinical study was approved by the Ethics Committee for Human Research of the First Affiliated Hospital of Guangzhou Medical University [EC-2024-026 (XJS)-02]. All procedures performed in the studies were in accordance with the 1975 Declaration of Helsinki (as revised in 2013), and written informed consent was obtained from all individual participants included in the study.\u003c/p\u003e\n\u003c/div\u003e\n\u003ch2 class=\"Heading\"\u003e\u003cstrong\u003eRobotic-assisted Optical Navigation System\u003c/strong\u003e\u003c/h2\u003e\n\u003cp\u003eThe robotic-assisted optical navigation system (TH-S1, TrueHealth Medical Technology Co., Ltd., Hengqin, China), employed in this study and specifically engineered for interventional procedures, has obtained approval from the National Medical Products Administration (NMPA) as a class III medical device. It consists of three core components: an optical navigation system, a surgical planning system, and a robotic arm positioning and puncture system (Fig. \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003eThe optical navigation system is utilized to precisely track the actual position and orientation of the patients by detecting location trackers via a wireless technique. It also monitors dynamic respiration with a breathing curve displayed on the user interface, providing real-time feedback to indicate the optimal time for needle insertion. The surgical planning system enables the reconstruction of a visualized three-dimensional (3D) model encompassing pulmonary nodules, vessels, bronchi, bone structures, and skin. It facilitates the creation of a comprehensive needle insertion trajectory plan, as determined by physicians, and subsequently converts the optimal plan into the physical surgical environment. The robotic arm positioning and puncture system autonomously moves to the target position, following a predetermined trajectory with high precision while maintaining stable needle holding and guiding needle insertion.\u003c/p\u003e\n\u003ch3\u003ePreoperative imaging and 3D reconstruction\u003c/h3\u003e\n\u003cp\u003eOn the day of the procedure, the physician, anesthetist, and radiologist collaborated to perform CT-guided robotic-assisted cryoablation with local or general anesthesia for nonsurgical candidates. The appropriate patient posture on the CT bed was determined according to the lesion location. Skin-adhering fixation devices were placed at the projected surface location of the lung lesion, after which the patient underwent the initial CT scan (NeuViz 128, Neusoft Medical Systems Co., Ltd., Shenyang, China, 120 kV, auto mAs, slice thickness 0.625 mm). During the cryoablation process, all the CT images were stored in DICOM format. The initial CT data were subsequently uploaded to a computer-assisted surgery system (Hisense, Qingdao, China) for comprehensive 3D reconstruction of anatomical structures, as mentioned above.\u003c/p\u003e\n\u003ch3\u003eNavigation planning and robotic-assisted percutaneous puncture\u003c/h3\u003e\n\u003cp\u003eThe optical camera captured accurate spatial information of the nodule from the locator and automatically registered the 3D model with the actual body position of the patient via nodule coordinates derived from the CT images. The surgical planning module subsequently considers both the spatial location of the nodule and the respiratory motion curve of the patient to determine the optimal needle insertion trajectory while avoiding major blood vessels and other critical anatomical structures. The robotic arm stably guided the needle holder along the planned path to the designated surface location on the basis of predefined puncture points, angles, and depths. Following local infiltration anesthesia at the target site or general anesthesia, the operator inserted the cryoprobe under the guidance of the holder, with real-time needle depth displayed on the system interface. Once the cryoprobe was accurately positioned at the target, location the final ablation of the nodule was initiated.\u003c/p\u003e\n\u003ch3\u003eCryoablation Procedure\u003c/h3\u003e\n\u003cp\u003eThe platelet count, international normalized ratio, prothrombin time, and partial thromboplastin time were determined before the procedure. Cryoablation was performed by the same respiratory physician (Yanwei Chen), who has ove\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003er\u003c/span\u003e 20 years of experience in pulmonary diagnosis and treatment, using a commercially available argon and helium gas-based VISUAL ICE Cryoablation System (Boston Scientific, Marlborough, MA, USA) with an number of 17-gauge cryoprobes. The distance between the edge of the nodule and that of the nearer cryoprobe was kept within 1 cm, whereas the distance between the 2 cryoprobes was \u0026lt;\u0026thinsp;1.5 cm. On the basis of lesion characteristics, three freezing-thawing cycles are commonly applied. Each cycle consisted of 5 minutes, 10 minutes, 10 minutes of freezing and 3 minutes interval of thawing. CT scans were acquired immediately after the procedure to assess the ablation zone and complications. The edge of the ice ball was 0.5 cm larger than the edge of the lesion to ensure that the nodule was thoroughly ablated, thereby achieving satisfactory clinical outcomes.\u003c/p\u003e\n\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\n \u003ch2\u003ePulmonary Function Evaluation\u003c/h2\u003e\n \u003cp\u003ePulmonary function tests were conducted by the same respiratory lab technicians in the First Affiliated Hospital of Guangzhou Medical University with a MasterScreen pulmonary function test system (Jeager) according to the guidelines of the American Thoracic Society (ATS). The forced expiratory volume in the first second (FEV\u003csub\u003e1\u003c/sub\u003e), percent to the predictive value of FEV\u003csub\u003e1\u003c/sub\u003e (FEV\u003csub\u003e1\u003c/sub\u003e% predicted), forced vital capacity (FVC), percent to the predictive value of FVC (FVC% predicted), FEV\u003csub\u003e1\u003c/sub\u003e-to-FVC ratio (FEV\u003csub\u003e1\u003c/sub\u003e/FVC%), percent to the predictive value of FEV\u003csub\u003e1\u003c/sub\u003e/FVC% (FEV\u003csub\u003e1\u003c/sub\u003e/FVC% predicted), and percent to the predictive value maximal mid-expiratory flow percentage (MMEF% predicted) were recorded from the pulmonary function test before and after CT-guided robotic-assisted cryoablation treatment. All patients underwent pulmonary function testing three times, and the optimal value was recorded.\u003c/p\u003e\n\u003c/div\u003e\n\u003ch3\u003eFollow-up\u003c/h3\u003e\n\u003cp\u003eFollow-up chest radiographs and contrast CT scans performed the following day were aimed at evaluating the detection of the adverse events and the technical efficacy rate. Follow-up dynamic CT chest scans of patients were carried out at 1 week, 1 month, and at 3 month intervals. In this study, evaluation of local control or prognosis was not conducted due to the short postoperative follow-up duration.\u003c/p\u003e\n\u003ch3\u003eCumulative sum (CUSUM) Learning Curve Analysis\u003c/h3\u003e\n\u003cp\u003eThe learning curve evaluation adopted the CUSUM method with the cusum (v0.4.1) R package, which visualizes patterns in the data by converting raw data into an accumulation of deviations from the average value [\u003cspan class=\"CitationRef\"\u003e33\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e34\u003c/span\u003e]. Patients with a single lesion were categorized in chronological order, and the duration of needle placement (performed by the same physician) was recorded to calculate the CUSUM value as follows:\u003c/p\u003e\n\u003cp\u003e\u003cimg src=\"https://myfiles.space/user_files/58895_8739fc6c57c1c19a/58895_custom_files/img1759228185.png\" width=\"278\" height=\"98\"\u003e\u003c/p\u003e\n\u003cp\u003ewhere \u003cspan class=\"InlineEquation\"\u003e\u003cspan class=\"mathinline\"\u003e\\(\\:{P}_{i}\\)\u003c/span\u003e\u003c/span\u003e and \u003cspan class=\"InlineEquation\"\u003e\u003cspan class=\"mathinline\"\u003e\\(\\:\\stackrel{-}{P}\\)\u003c/span\u003e\u003c/span\u003e indicate the individual puncture time and the mean puncture time, respectively.\u003c/p\u003e\n\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\n \u003ch2\u003eData collection and definition\u003c/h2\u003e\n \u003cp\u003ePreoperative data for each patient and nodule, including age, sex, smoking history, ECOG PS, BMI, pulmonary function, pulmonary background disease, maximum diameter, location, type, and rib obstruction status, were systematically collected.\u003c/p\u003e\n \u003cp\u003eIntraoperative data included decubitus position, chest wall thickness, distance between the pleura and nodule, needle trajectory length, out-of-plane puncture, technical success rate, number of needle adjustments, deviation, time, CT scans, DLPs for needle insertion, and total procedural duration. Technical success was defined as completing the procedure via robotic guidance without major system deficiencies, robotic arm collisions, or significant manual needle adjustments [\u003cspan class=\"CitationRef\"\u003e35\u003c/span\u003e]. The number of needle adjustments was counted from the initial insertion to the final confirmation of reaching the target nodule. The deviation was calculated as the distance from the needle tip position to the nodule center. The number of CT scans each patient underwent was recorded from the initial CT scan for 3D reconstruction and trajectory planning to the validation CT scan of proper needle placement, as well as the DLP calculation. The duration of needle placement was determined by the difference between the two timestamps of the initial CT scan and the validation CT scan, as mentioned above. The total procedural duration was defined as the time from the initial preoperative CT scan to the final CT scan after the cryoablation procedures.\u003c/p\u003e\n \u003cp\u003ePostoperative data included the technical efficacy rate and the postoperative complications. The technical efficacy of cryoablation was demonstrated by the complete ablation of the target nodule, with evidence obtained from imaging immediately following the last ablation procedure and follow-up imaging at 1, 3, 6, 9, and 12 months after treatment [\u003cspan class=\"CitationRef\"\u003e36\u003c/span\u003e]. Puncture-related complications, including minor (grades 1\u0026ndash;2) and major complications (grades 3\u0026ndash;4), were classified according to the adverse event classification from the Society of Interventional Radiology (SIR) Standards of Practice Committee [\u003cspan class=\"CitationRef\"\u003e37\u003c/span\u003e].\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\n \u003ch2\u003eStatistical analysis\u003c/h2\u003e\n \u003cp\u003eAll the statistical analyses were performed using R 4.2.2. Patient and nodule characteristics were summarized via means with standard deviations or medians with ranges for continuous variables. Categorical variables were presented as numbers with percentages. For comparisons of exploratory analyses between two groups or among multiple groups, the Mann-Whitney U test and Kruskal-Wallis \u003cem\u003etest\u003c/em\u003e were used, respectively, for the continuous variables. Notably, the pre- and postoperative changes in pulmonary function parameters were assessed using the paired Wilcoxon signed-rank test. The Spearman rank correlation test was used to evaluate correlations between variables, with the corresponding Spearman correlation coefficient (R\u003csub\u003eSpearman\u003c/sub\u003e) reported. The Jonckheere-Terpstra trend test for the continuous variables was used to validate the CUSUM learning curve analysis. Statistical significance was set at a \u003cem\u003eP\u003c/em\u003e-value of less than 0.05.\u003c/p\u003e\n\u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e\u003ch2\u003ePatient and Nodule Baseline Characteristics\u003c/h2\u003e\u003cp\u003eFrom April 18, 2024, to May 28, 2025, a total of 50 consecutive patients were prospectively enrolled and underwent initial screening. After excluding those with multiple lesions, lesion sizes exceeding 3 cm, or procedures not performed as planned according to the protocol, 37 patients with single nodules were ultimately included in the study (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). Among these patients, 20 (54.05%) were female, and 23 (62.16%) had no smoking history. The median age was 60 years (range: 35 to 77 years), with a mean body mass index (BMI) of 22.81\u0026thinsp;\u0026plusmn;\u0026thinsp;3.04 kg/m\u0026sup2; (range: 15.40 to 29.88 kg/m\u0026sup2;). Additionally, 36 (97.30%) patients had an Eastern Cooperative Oncology Group performance status (ECOG PS) score of \u0026le;\u0026thinsp;1. Of the 37 patients, 12 (32.43%) underwent cryoablation alone with the assistance of the TH-S1 system, while 25 (67.57%) underwent cryoablation in combination with biopsy. With respect to baseline pulmonary function, the average FEV\u003csub\u003e1\u003c/sub\u003e was 2.08\u0026thinsp;\u0026plusmn;\u0026thinsp;0.86 L (range: 0.56 to 4.13 L), the average FVC was 2.95\u0026thinsp;\u0026plusmn;\u0026thinsp;0.81 L (range: 1.29 to 5.00 L), the average FEV\u003csub\u003e1\u003c/sub\u003e/FVC% was 69.15% \u0026plusmn; 17.70% (range: 25.13\u0026ndash;87.20%), and the average MMEF% predicted was 52.12% \u0026plusmn; 28.24% (range: 6.21\u0026ndash;106.27%). Meanwhile, 9 (24.32%) patients were previously diagnosed with pulmonary background diseases associated with emphysema (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eClinical characteristics of the patients.\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"2\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCharacteristics \u003cem\u003e(n\u0026thinsp;=\u0026thinsp;37)\u003c/em\u003e\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAge (years)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e60.00 [35.00, 77.00]\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGender (n,%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eFemale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e20 (54.05%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e17 (45.95%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSmoking (n,%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eYes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e14 (37.84%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e23 (62.16%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eECOG PS (n,%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e28 (75.68%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e8 (21.62%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e1 (2.70%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBMI (kg/m\u003csup\u003e2\u003c/sup\u003e)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e22.81\u0026thinsp;\u0026plusmn;\u0026thinsp;3.04 [15.40, 29.88]\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eFEV1 (L)*\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e2.08\u0026thinsp;\u0026plusmn;\u0026thinsp;0.86 [0.56, 4.13]\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eFVC (L)*\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e2.95\u0026thinsp;\u0026plusmn;\u0026thinsp;0.81 [1.29, 5.00]\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eFEV1/FVC (%)*\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e69.15\u0026thinsp;\u0026plusmn;\u0026thinsp;17.70 [25.13, 87.20]\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMMEF75/25 (L/s)*\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e52.12\u0026thinsp;\u0026plusmn;\u0026thinsp;28.24 [6.21, 106.27]\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eEmphysema (n,%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eYes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e9 (24.32%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e28 (75.68%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePercutaneous procedure (n,%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCryoablation\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e12 (32.43%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBiopsy and cryoablation\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e25 (67.57%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"2\"\u003eCharacteristics are expressed as median [range], mean \u0026plusmn; standard deviation [range], or number (%).\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"2\"\u003e* indicated that nine patients who did not have the pulmonary function results were excluded.\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"2\"\u003eECOG PS, Eastern Cooperative Oncology Group performance status; BMI, body mass index; FEV1, forced expiratory volume in the first second; FVC, forced vital capacity; MMEF, maximal mid-expiratory flow curve.\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eFor nodule characteristics, the nodules were categorized as pure ground-glass nodules (GGNs) [8 (21.62%)], mixed GGNs [7 (18.92%)], and solid nodules [22 (59.46%)]. The distribution of nodules across the lung lobes was as follows: 8 (21.62%) in the left lower lobe (LLL), 10 (27.03%) in the left upper lobe (LUL), 9 (24.32%) in the right lower lobe (RLL), 8 (21.62%) in the right upper lobe (RUL), and 2 (5.41%) in the right middle lobe (RML). The average maximum diameter of target nodules was 13.81\u0026thinsp;\u0026plusmn;\u0026thinsp;6.42 mm (range: 3.00 to 30.00 mm), with rib obstruction noted in 3 (8.11%) of the nodules, indicating the challenging nature of needle insertion (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eClinical characteristics of the nodules.\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"2\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCharacteristics\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNodule maximum diameter (mm)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e13.81\u0026thinsp;\u0026plusmn;\u0026thinsp;6.42 [3.00, 30.00]\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLobar location (n,%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLLL\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e8 (21.62%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLUL\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e10 (27.03%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eRLL\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e9 (24.32%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eRML\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2 (5.41%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eRUL\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e8 (21.62%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNodule types (n,%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMixed GGN\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e7 (18.92%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePure GGN\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e8 (21.62%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSolid\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e22 (59.46%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eRib obstruction (n,%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eYes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e3 (8.11%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e34 (91.89%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePathology (n,%)\u003csup\u003e#\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAdenocarcinoma\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e19 (51.35%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSquamous cell carcinoma\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e3 (8.11%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMetastasis\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1 (2.70%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAtypical adenomatous hyperplasia\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e4 (10.81%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eInflammation or infection\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e6 (16.22%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"2\"\u003eCharacteristics are expressed as mean \u0026plusmn; standard deviation [range] or number (%).\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"2\"\u003e\u003csup\u003e#\u003c/sup\u003e indicated that four patients who did not have the histopathology results were excluded.\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"2\"\u003eLLL, left lower lobe; LUL, left upper lobe; RLL, right lower lobe; RML, right middle lobe; RUL, right upper lobe; GGN, ground-glass nodule.\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eIn terms of pathological diagnosis, among all patients, 19 (51.35%) had adenocarcinoma, 3 (8.11%) had squamous cell carcinoma, 1 (2.70%) had malignant metastasis, 4 (10.81%) had atypical adenomatous hyperplasia, and 6 (16.22%) had inflammation or infection (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec15\" class=\"Section2\"\u003e\u003ch2\u003eTechnical characteristics and outcomes of robotic-assisted cryoablation procedures\u003c/h2\u003e\u003cp\u003eAll procedures were performed successfully using the TH-S1 system, with 14 (37.84%) patients in the supine puncture position, 8 (21.62%) in the lateral position, and 15 (40.5%) in the prone position. The total needle trajectory length, chest wall thickness, and distance to the pleura were 62.66\u0026thinsp;\u0026plusmn;\u0026thinsp;15.87 mm (range: 34.70 to 94.80 mm), 37.60\u0026thinsp;\u0026plusmn;\u0026thinsp;11.05 mm (range: 18.70 to 63.60 mm), and 23.92\u0026thinsp;\u0026plusmn;\u0026thinsp;12.92 mm (range: 8.00 to 61.00 mm), respectively. Specifically, a total of 14 (37.84%) nodules underwent out-of-plane punctures in the present study. Two successful robotic-assisted cryoablation procedures with a high level of difficulty are illustrated in Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e and Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eDuring the procedures, the average number of needle adjustments was 0.82\u0026thinsp;\u0026plusmn;\u0026thinsp;1.19 (range: 0.00 to 5.00), with a mean deviation of 3.47\u0026thinsp;\u0026plusmn;\u0026thinsp;2.47 mm (range: 0.00 to 10.00 mm). Moreover, the average number of CT scans was 3.44\u0026thinsp;\u0026plusmn;\u0026thinsp;1.65 (range: 2.00 to 8.00), with an average DLP of 638.86\u0026thinsp;\u0026plusmn;\u0026thinsp;434.44 mGy*cm (range: 260.06 to 2239.42 mGy*cm). The mean duration of needle placement was 15.95\u0026thinsp;\u0026plusmn;\u0026thinsp;5.06 min (range: 9.00 to 38.00 min), whereas the total procedural duration was 99.32\u0026thinsp;\u0026plusmn;\u0026thinsp;32.00 min (range: 55.00 to 166.00 min). Notably, the deviation was found to be significantly correlated with the lobar location, which was more prominent in the lower lobe (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.013), but no significant correlation was observed with the nodule type (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.640), size (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.477), distance to the pleura (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.491), chest wall thickness (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.241), needle trajectory length (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.179), decubitus position (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.499), or pulmonary function status of the patient (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.398 for the presence or absence of emphysema, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.901 for different pulmonary function statuses) (Figure \u003cspan refid=\"MOESM1\" class=\"InternalRef\"\u003eS1\u003c/span\u003e and S2).\u003c/p\u003e\u003cp\u003eDuring the postoperative observations, no severe complications occurred, while 8 (21.62%) cases experienced minor complications, including 5 (13.51%) cases of immediate pneumothorax, 2 (5.41%) cases of delayed pneumothorax, and 1 (2.70%) case of hemorrhage. Furthermore, the median duration of follow-up was 39 days. After excluding cases with missing or incomplete follow-up data, the complete ablation zone coverage on intraoperative images and the 1-month imaging follow-up confirmed a 100% technical efficacy rate for robotic-assisted cryoablation. Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e summarizes the intraoperative and postoperative technical characteristics and outcomes.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eTechnical characteristics and outcomes of robotic-assisted cryoablation procedures.\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"2\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eVariables \u003cem\u003e(n\u0026thinsp;=\u0026thinsp;37)\u003c/em\u003e\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDecubitus position (n,%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLateral\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e8 (21.62%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eProne\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e15 (40.54%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSupine\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e14 (37.84%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eOut of Plane (n,%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eYes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e14 (37.84%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e23 (62.16%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eChest wall thickness (mm)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e37.60\u0026thinsp;\u0026plusmn;\u0026thinsp;11.05 [18.70, 63.60]\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDistance from the pleural surface (mm)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e23.92\u0026thinsp;\u0026plusmn;\u0026thinsp;12.92 [8.00, 61.00]\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNeedle trajectory length (mm)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e62.66\u0026thinsp;\u0026plusmn;\u0026thinsp;15.87 [34.70, 94.80]\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAnesthesia (n,%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLocal\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e8 (21.62%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGeneral\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e29 (78.38%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTechnical success rate (n, %)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e37 (100%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNumber of needle adjustment (mm)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.82\u0026thinsp;\u0026plusmn;\u0026thinsp;1.19 [0.00, 5.00]\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDeviation (mm)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e3.47\u0026thinsp;\u0026plusmn;\u0026thinsp;2.47 [0.00, 10.00]\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDuration needle placement (min)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e15.95\u0026thinsp;\u0026plusmn;\u0026thinsp;5.06 [9.00, 38.00]\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNumber of CT scans for needle insertion\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e3.44\u0026thinsp;\u0026plusmn;\u0026thinsp;1.65 [2.00, 8.00]\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDLPs during needle insertion (mGy\u0026middot;cm)*\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e638.86\u0026thinsp;\u0026plusmn;\u0026thinsp;434.44 [260.06, 2239.42]\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eIntraoperative complications\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTotal procedural duration (min)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e99.32\u0026thinsp;\u0026plusmn;\u0026thinsp;32.00 [55.00, 166.00]\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTechnical efficacy rate (%)\u003csup\u003e#\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e35 (100%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eComplications (n,%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMajor complications (grade 3\u0026ndash;4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMinor complications (grade 1\u0026ndash;2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e8 (21.62%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eImmediate pneumothorax\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e5 (13.51%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDelayed pneumothorax\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2 (5.41%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHemorrhage\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1 (2.70%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"2\"\u003eCharacteristics are expressed as mean \u0026plusmn; standard deviation [range] or number (%).\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"2\"\u003e* indicated that one patient missing the result of the DLPs during needle insertion was excluded.\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"2\"\u003e\u003csup\u003e#\u003c/sup\u003e indicated that two patients missing the follow-up data were excluded.\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"2\"\u003eCT, computed tomography; DLPs, dose length products.\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eTo evaluate the clinical minimally invasive nature and patient tolerance of the robotic-assisted cryoablation technique, serial pulmonary function evaluations were conducted in 11 patients whose baseline and postoperative pulmonary function data were available. Among these patients, the mean baseline values for FEV\u003csub\u003e1\u003c/sub\u003e, FVC, FEV\u003csub\u003e1\u003c/sub\u003e/FVC%, and MMEF% predicted were 2.48\u0026thinsp;\u0026plusmn;\u0026thinsp;0.96 L (range: 0.88 to 4.13 L), 3.53\u0026thinsp;\u0026plusmn;\u0026thinsp;1.06 L (range: 1.29 to 5.00 L), 74.03% \u0026plusmn; 13.67% (range: 37.00\u0026ndash;86.00%), and 59.03% \u0026plusmn; 27.62% (range: 10.69\u0026ndash;106.27%), respectively. Postoperatively, the corresponding values were 2.49\u0026thinsp;\u0026plusmn;\u0026thinsp;0.94 (range: 0.86 to 4.10), 3.32\u0026thinsp;\u0026plusmn;\u0026thinsp;1.06 (range: 1.24 to 5.07), 75.42% \u0026plusmn; 14.69% (range: 33.00\u0026ndash;85.00%), and 65.80% \u0026plusmn; 22.74% (range: 17.83\u0026ndash;90.00%). As expected, there were no significant changes in the pulmonary function between the baseline and postoperative periods on the basis of the above parameters and their percentage of predicted values (Fig.\u0026nbsp;\u003cspan refid=\"Fig5\" class=\"InternalRef\"\u003e5\u003c/span\u003e, Figure S3).\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec16\" class=\"Section2\"\u003e\u003ch2\u003eLearning Curve Evaluation\u003c/h2\u003e\u003cp\u003eThe duration of needle placement for each TH-S1 procedure was systematically recorded to facilitate the calculation of CUSUM values and subsequent validation analyses (Fig.\u0026nbsp;\u003cspan refid=\"Fig6\" class=\"InternalRef\"\u003e6\u003c/span\u003e). A total of 35 patients were enrolled in the final learning curve evaluation because two patients had a distinct intraoperative needle planning procedure compared with the other patients. As shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig6\" class=\"InternalRef\"\u003e6\u003c/span\u003eA, two pivotal cutoff points were identified at the 5th and 13th cases, thereby partitioning the learning curve into three distinct phases: Phase I (the initial 5 cases), Phase II (cases 6th to 13th ), and Phase III (after the 13th case). In Phase I, the duration of needle placement surpassed the average, and the learning curve showed a steep upward trend, corresponding to a significant increase in needle insertion time. In Phase II, the duration of needle placement remained above average, with the learning curve exhibiting a gradually increasing trend, indicating a decelerated rate of improvement compared with the initial phase. Upon reaching the 13th case, the duration of needle placement transitioned to falling below the average and maintained a consistent downward trend throughout Phase III. Further validation analyses confirmed a statistically significant reduction in the duration of needle placement, deviation, and associated number of CT scans across the three phases (Fig.\u0026nbsp;\u003cspan refid=\"Fig6\" class=\"InternalRef\"\u003e6\u003c/span\u003eB).\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003c/div\u003e"},{"header":"Disscussion","content":"\u003cp\u003eIn recent years, percutaneous cryoablation under CT guidance has been proven to be a safe and effective treatment modality for inoperable patients with pulmonary nodules [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e]. As a percutaneous puncture procedure, it depends on achieving conformal needle placement and precise puncture of therapeutic devices. Conversely, inaccurate localization may require repeated puncture attempts and multiple CT scans, resulting in longer procedural duration, potential radiation exposure, and increased risk of complications for the patient. As positioning navigation and robotic technologies have advanced, new tools and solutions have become available for overcoming the aforementioned problems [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e, \u003cspan additionalcitationids=\"CR26 CR27 CR28 CR29 CR30\" citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e]. This study utilized a novel robotic-assisted optical navigation system, the TH-S1, to achieve minimally invasive percutaneous cryoablation during CT-guided procedures. This technique demonstrated high feasibility and safety for treating pulmonary nodules, with high technical success and efficacy rates.\u003c/p\u003e\u003cp\u003eNavigation and robotic systems aim to improve the accuracy and efficiency of percutaneous image-guided interventions, and the autonomy and integration of advanced imaging and artificial intelligence (AI) may reflect their potential [\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e]. Currently, autonomy is continuously being improved toward incorporating planning, navigation, and assessment software, including image fusion, automated lesion segmentation, real-time tracking of needle trajectories, margin confirmation, heatmaps, or postoperative assessment [\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e]. In a recent study, Cornelis et al. [\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e] evaluated the autonomy of navigation and robotic systems for percutaneous image-guided interventions via an aggregate score consisting of the levels of autonomy in surgical robotics (LASR) classification system and the levels of integration of advanced imaging and AI (LIAI2) classification system. The LASR classification system ranges from no autonomy (0) to full autonomy (5). Similarly, the LIAI2 classification system ranges from independent imaging (0) to autonomous navigation (5). Despite currently available systems representing task-specific machines with limited functionality and not rising to the level of true robots, the Epione (Quantum) system [\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e, \u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e], which achieved the highest aggregate scores (1 for robot assistance and 3 for automated assistance), epitomizes the most advanced stage of the percutaneous image-guided interventional field in this report. This is similar to the TH-S1 system used in our research. The TH-S1 system offers several unique features: visualized 3D reconstruction of various anatomical components, real-time tracking of patient position and orientation, comprehensive trajectory planning, continuous recording of respiratory motion, and stable needle holding with guided insertion. These functions enhance the efficiency, accuracy, and safety of interventional planning and performance, resulting in a higher first-pass success rate in contrast to the conventional freehand stepwise needle advancement technique.\u003c/p\u003e\u003cp\u003e Previous studies in the literature have addressed the efficacy and safety of the TH-S1 system for CT-guided percutaneous preoperative localization, percutaneous transthoracic needle biopsy (PTNB), and thermoablation. Duan et al. [\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e] evaluated the robotic-assisted percutaneous localization technique for peripheral pulmonary nodules in the swine lung through fluorescent agent injection, reporting the mean deviation by measuring the 3D distance of 3.81\u0026thinsp;\u0026plusmn;\u0026thinsp;1.29 mm, with a surprising first-attempt success rate of 100% and a mean localization time of 14.69\u0026thinsp;\u0026plusmn;\u0026thinsp;4.67 min. As an animal experiment, deeper nodules under the pleural surface or the capability of tracking and compensating for patient respiratory motion were not considered. Thus, Liu et al. [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e] investigated the accuracy and safety of the same technique in clinical applications, still achieving a first-pass success rate of 100%, with a median deviation of 6.1 mm and a median localization time of 25.0 min, demonstrating satisfactory accuracy and holding promise for improving the percutaneous localization of lung nodules. Jing et al. [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e] conducted a prospective clinical study evaluating the TH-S1 system for percutaneous puncture of CT-guided thoracic and abdominal lesions, including biopsy and thermoablation. Compared with a control group punctured manually, the system demonstrated remarkable performance, with a considerably higher once-puncture success rate of 100% and a reduced number of CT scans averaging 3.03\u0026thinsp;\u0026plusmn;\u0026thinsp;0.18 times. Another real-world clinical study evaluated the feasibility and safety of the TH-S1 system for PTNB compared with the conventional freehand technique and assessed its generalizability across operators of different experience levels [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]. The robot-assisted navigation system could decrease the number of punctures, number of CT scans, and incidence of adverse events such as pneumothorax. This approach also reduces the influence of operator experience on PTNB and enhances its clinical applicability.\u003c/p\u003e\u003cp\u003eDespite the growing utilization of this system in CT-guided interventions for lung nodules, sufficient evidence regarding its clinical value in lung cryoablation remains to be determined. Moreover, given that no clinical investigations on robotic-assisted percutaneous cryoablation have been reported to date, and that previous research on conventional free-hand percutaneous puncture has focused mainly on dynamic pulmonary function changes, adverse events, treatment efficacy, and influence on immunologic mechanisms [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e, \u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e], this prospective study was performed to further evaluate the clinical value of the robotic-assisted navigation system. In the present study, the prospective cohort consisted of patients with pulmonary nodules of various sizes, lung lobar locations, lesion types, distance to the pleura, and decubitus position to demonstrate the generalizability of the findings to various lesion settings and the system's capacity to guide punctures in different clinical practices. Consistent with prior findings, the respiratory-induced motion amplitude of nodules is greater in the lower lobes, resulting in inaccurate localization during the CT-guided percutaneous lung puncture [\u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e]. Nevertheless, owing to the lack of control group data on deviations of nodules in different lobar locations, we are unable to determine whether the robotic-assisted puncture technique confers any benefits to nodules located in the lower lobes during the puncture procedure. In addition, the accuracy of the robotic-assisted cryoablation was not affected by the nodule type, the maximum diameter of the nodule, the distance to the pleura, or the decubitus position, a finding similar to that reported in a previous study [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eFew studies have investigated the learning process of CT-guided interventional radiology under robotic assistance [\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e]. Although the sample size of this pilot study was limited, CUSUM analysis was performed as an exploratory analysis and suggested that the learning curve of robotic-assisted CT-guided percutaneous cryoablation for pulmonary nodules comprised three distinct phases. These phases of the learning curve were identified by two cutoff points (case 5 and case 13), at which the inclination and trend of the curves sharply changed. As previously mentioned, the CUSUM curve reflects sequential changes relative to an average value. Thus, the two cutoff points on the CUSUM curve represent two critical points in the learning process regarding the duration of needle placement. In this study, first, Phase I, as the initial learning period, involved gradually acquiring technical competence and skills to significantly reduce the puncture time (cases 1 to 5). Second, Phase II, as the consolidation period, could be interpreted as the accumulation of additional experience after the initial learning curve and as the consolidation of the experience gained during the first phase (cases 6 to 13). Finally, Phase III represented the mastery period, suggesting the acquisition of a greater competence in the execution of this preoperative localization procedure under robotic guidance (cases 14 to 35). Furthermore, as expected, the duration of needle placement, deviation, and number of CT scans significantly decreased across the three distinct phases. Additionally, these findings could help less experienced physicians accurately understand the benefits of using a robotic-assisted optical navigation system in CT-guided percutaneous interventional procedures.\u003c/p\u003e\u003cp\u003eIn other words, one of the major advantages of the robotic-assisted navigation system is that it can reduce adverse effects from the first-time use of new technology [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]. Consequently, all procedures were performed successfully, resulting in a notable technical success rate of 100% and a 100% technical efficacy rate, as evidenced by intraoperative and 1-month follow-up imaging, indicating the feasibility and effectiveness of the TH-S1 system in clinical practice. During the postoperative observation, no major complications were reported; eight minor complications occurred, including five cases of immediate pneumothorax, two cases of delayed pneumothorax, and one case of hemorrhage, indicating the safety of the TH-S1 system. Delayed pneumothorax is classified as a relatively rare complication, defined as a pneumothorax occurring as early as 4 hours after the procedure [\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e]. A previous study has demonstrated that a history of multiple punctures in small lesions located in the upper lobes is associated with an increased risk of delayed pneumothorax development, which is consistent with the condition observed in our two patients, whose lesions were both located in the right upper lobe of the lung [\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e]. Regarding lesions in upper lobes as a risk factor of delayed pneumothorax, a reasonable explanation is that pulmonary air in the upper lobes with less movement may escape slowly, resulting in late appearance of pneumothorax. Conversely, lesions involving lower lobes with greater mobility and higher aeration may result in early appearance of pneumothorax. Moreover, the osmotic effects of cryoablation, which induce vasoconstriction and thereby diminish blood flow to the treated tissue, may also aid in reducing intraoperative bleeding [\u003cspan citationid=\"CR47\" class=\"CitationRef\"\u003e47\u003c/span\u003e]. The bleeding risk can be mitigated by avoiding the puncture of large vessels, or by using active thawing at the end of the procedure to avoid cracks in the ice. Nevertheless, among these patients, all patients improved following rest, oxygen therapy, conservative treatment, and intensive clinical monitoring.\u003c/p\u003e\u003cp\u003eThe present study has several limitations that should be acknowledged. First, this was a single-center study with a small sample size, which limits the generalizability of our findings. Second, the lack of a freehand control group makes it difficult to accurately determine the superiority attributed to the TH-S1 system. At present, both in China and internationally, only a limited number of clinical centers have implemented robotic-assisted percutaneous cryoablation. Nevertheless, our findings provide valuable insights and references for the clinical promotion of this technology. Further large-scale randomized studies are warranted to offer a more comprehensive evaluation of the currently available CT-guided robotic-assisted optical navigation system.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eIn conclusion, CT-guided percutaneous cryoablation assisted by the TH-S1 system is safe, feasible, minimally invasive, and highly accurate for treating pulmonary nodules, particularly in patients for whom surgery is contraindicated. The TH-S1 system has the potential to serve as a valuable auxiliary tool for CT-guided lung interventions in clinical practice.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAcknowledgments\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll the authors substantially contributed to the conception of the work and approved the final version of the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eClinical trial number\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eFunding\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis work was financially supported by the National Natural Science Foundation of China (82070096).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eStatement of Ethics\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study protocol was reviewed and approved by the Ethics Committee for Human Research of the First Affiliated Hospital of Guangzhou Medical University\u0026nbsp;[EC-2024-026 (XJS)-02]. All procedures performed in the studies were in accordance with the 1975 Declaration of Helsinki (as revised in 2013), and written informed consent was obtained from all individual participants included in the study.\u003c/p\u003e\n\u003cp id=\"_Toc472330565\"\u003e\u003cstrong\u003e\u003cem\u003eConflict of\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003eInterest Statement\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors have no conflicts of interest to declare.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAuthor Contributions\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll the authors meet the criteria for authorship recommended by the International Committee of Medical Journal Editors and critically revised the manuscript for important intellectual content. Conceptualization: S.L., and Y.C.; study design, data curation, formal analysis, validation, writing - original draft, and writing - review and editing: S.L., Y.C., X.W., W.W., and L.Y.; data curation, formal analysis, investigation, methodology, and validation:\u0026nbsp;X.S., J.C., W.L., X.Z.,\u003csup\u003e\u0026nbsp;\u003c/sup\u003eX.Y., and X.W.; data curation, formal analysis, and writing - review and editing: J.L., and G.L.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eData\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003eA\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003evailability\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003eS\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003etatement\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe data that support the findings of this study may be available upon reasonable request from the corresponding authors.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eBray F, Laversanne M, Sung H, et al. 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J Thorac Dis. 2024;16(7):4263-4274. doi:10.21037/jtd-24-198\u003c/li\u003e\n \u003cli\u003eBonnet B, de Ba\u0026egrave;re T, Beunon P, Feddal A, Tselikas L, Deschamps F. Robotic-assisted CT-guided percutaneous thermal ablation of abdominal tumors: An analysis of 41 patients. Diagn Interv Imaging. 2024;105(6):227-232. doi:10.1016/j.diii.2024.01.005\u003c/li\u003e\n \u003cli\u003ePuijk RS, Ahmed M, Adam A, et al. Consensus Guidelines for the Definition of Time-to-Event End Points in Image-guided Tumor Ablation: Results of the SIO and DATECAN Initiative. Radiology. 2021;301(3):533-540. doi:10.1148/radiol.2021203715\u003c/li\u003e\n \u003cli\u003eKhalilzadeh O, Baerlocher MO, Shyn PB, et al. Proposal of a New Adverse Event Classification by the Society of Interventional Radiology Standards of Practice Committee [published correction appears in J Vasc Interv Radiol. 2018 Jan;29(1):146. doi: 10.1016/j.jvir.2017.10.012.]. 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Published 2024 Nov 18. doi:10.1186/s13244-024-01822-5\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Robotic-assisted, navigation system, pulmonary nodule, percutaneous cryoablation","lastPublishedDoi":"10.21203/rs.3.rs-7395827/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7395827/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e\u003cp\u003ePercutaneous cryoablation under imaging guidance is an effective therapeutic modality for pulmonary nodules, but the conventional technique relies on surgical complexity and physician experience. Computed tomography (CT)-guided robotic-assisted percutaneous puncture technique provides three-dimensional (3D) reconstruction, optimal needle trajectory planning, and monitoring of real-time respiratory motion, thereby enabling safe ablation of lung nodules. This study aimed to clinically evaluate the feasibility and safety of a robotic-assisted optical navigation system when utilized for CT-guided percutaneous cryoablation of pulmonary nodules.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003ePatients who underwent CT-guided percutaneous cryoablation via a robotic-assisted optical navigation system were prospectively enrolled in our study. The primary outcomes were the technical success rate and the technical efficacy rate, and the preoperative, intraoperative, and postoperative variables were recorded and analyzed for each patient.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003eA total of 37 consecutive patients with a single nodule were ultimately enrolled in the present study. The technical success rate was 100%, and the technical efficacy rate of robotic-assisted cryoablation was 100% with no recurrence during the 1-month follow-up. The average number of needle adjustments per nodule was 0.82\u0026thinsp;\u0026plusmn;\u0026thinsp;1.19 in this study, with a mean deviation of 3.47\u0026thinsp;\u0026plusmn;\u0026thinsp;2.47 mm. The mean numbers of CT acquisitions and dose length products (DLPs) used during needle insertion were 3.44\u0026thinsp;\u0026plusmn;\u0026thinsp;1.65 and 638.86\u0026thinsp;\u0026plusmn;\u0026thinsp;434.44 mGy*cm, respectively. The duration of needle placement was 15.95\u0026thinsp;\u0026plusmn;\u0026thinsp;5.06 min, whereas the total procedural duration was 99.32\u0026thinsp;\u0026plusmn;\u0026thinsp;32.00 min. Notably, the deviation was found to be significantly correlated with the lobar location and was more prominent in the lower lobe. However, no significant correlations were observed with the nodule type, size, distance to the pleura, chest wall thickness, needle trajectory length, decubitus position, or the pulmonary function status of the patient. Moreover, no significant changes were found in the pulmonary function of the patients before or after the treatment. No major grade\u0026thinsp;\u0026ge;\u0026thinsp;3 complications were observed. However, among the minor complications, there were 5 cases (13.51%) of immediate pneumothorax, 2 cases (5.41%) of delayed pneumothorax, and 1 case (2.70%) of hemorrhage.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e\u003cp\u003eThe robotic-assisted optical navigation system is feasible, safe and effective for CT-guided percutaneous cryoablation of pulmonary nodules.\u003c/p\u003e","manuscriptTitle":"Feasibility and safety of a robotic-assisted optical navigation system for pulmonary nodule percutaneous cryoablation: a prospective, single-center, single-arm pilot study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-09-30 10:57:57","doi":"10.21203/rs.3.rs-7395827/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"e0db98fc-ea9a-41c6-b66f-6b43da4e7889","owner":[],"postedDate":"September 30th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-10-09T07:38:29+00:00","versionOfRecord":[],"versionCreatedAt":"2025-09-30 10:57:57","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7395827","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7395827","identity":"rs-7395827","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}