Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
NCT07906535
· ctgov
not_yet_recruiting
- Enrollment
- 41
- Start
- 2026-11-01
- Completion
- 2029-03-31
- Last updated
- 2026-10-30
- Has results
- False
- Countries
- Czechia
Conditions
Tagged with
Interventions
-
Myoblate Radiofrequency Ablation System (Mygen V-1000 generator)
DEVICE
Radiofrequency ablation of the focal adenomyotic lesion with an ultrasound-guided needle electrode inserted transvaginally; high-frequency alternating current heats the tissue and causes coagulative necrosis. Settings (mode, target temperature, power, duration) follow the manufacturer's instructions for use and clinical judgement. The device is intended by the manufacturer for ablation of uterine fibroids; use in adenomyosis is off-label. Generator serial number and electrode lot/REF are recorded for every procedure.
Eligibility criteria
Inclusion Criteria:
* Women aged 18 years or older with focal (circumscribed) adenomyosis confirmed by transvaginal ultrasound (TVUS) and described using MUSA terminology
* Symptoms (dysmenorrhea and/or heavy menstrual bleeding) persisting despite conservative treatment or intolerance of conservative treatment
* Wish to preserve the uterus
* Signed informed consent and consent to personal data processing
Exclusion Criteria:
* Pregnancy (excluded by pregnancy test before the procedure) or planned pregnancy during the study; suspected malignancy; active pelvic infection; intrauterine device in situ
* Contraindication to the procedure or anesthesia according to the investigator
* Known history or intraoperatively suspected endometriosis, or significant pelvic adhesions
* Start or change of hormonal treatment of adenomyosis within 6 months before enrollment
* Inability to understand the patient information or to complete the questionnaires independently; current participation in another interventional study
License: public-domain-us
· commercial use OK
· attribution required
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine