ICG for Visualization of the Ureters in DIE

NCT05206279 · ctgov completed
Enrollment
51
Start
2023-06-26
Completion
2024-09-01
Last updated
2026-06-17
Has results
False
Countries
Switzerland

Conditions

Visualization of Ureters in Gynecological SurgeryDeep Infiltrative EndometriosisICG (Indocyanine Green)Near Infrared ImagingLaparoscopy

Tagged with

endometriosis

Interventions

Eligibility criteria
Inclusion Criteria: * Informed Consent as documented by signature * Age 18 or older * Premenopausal status (menopause is defined as amenorrhea lasting one year or longer) * Proven (by laparoscopy or MRI) or highly suspected (ultrasound or clinically) deep infiltrating endometriosis Exclusion Criteria: * No DIE detectable intraoperatively * Known or suspected allergy to iodine, shellfish, or ICG dye * Hyperthyroid metabolic state (excluding treated hyperthyroidism with euthyroid metabolic state) * Severe renal insufficiency (GFR \< 30ml/min) * Simultaneous therapy with beta-blockers * Pregnant (positive human chorionic gonadotropin in the blood) or breastfeeding women * Intention to become pregnant during the course of the study * Inability to follow the procedures of the study (due to language problems, psychological disorders, dementia) * Previous history of radiation therapy of the pelvis * Presence of medical conditions contraindicating general anesthesia or standard laparoscopic surgery * Active, non treated urinary tract infection * Active pyelonephritis * Women having undergone surgery for reimplantation of the ureters (UCNS) or nephrostomy
License: public-domain-us · commercial use OK · attribution required
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine

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