Clinical Research Directory
Browse clinical research sites, groups, and studies.
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Sponsor: University Hospital Pilsen
Summary
This single-center, single-arm, open-label study evaluates the efficacy and safety of ultrasound-guided radiofrequency ablation (RFA) in women with symptomatic focal adenomyosis who wish to preserve the uterus. RFA is performed transvaginally under general anesthesia using the Myoblate system. Participants are followed at 3, 6 and 12 months (optionally 24 months) with transvaginal ultrasound and validated questionnaires (VAS, PBAC, EQ-5D-5L). The primary outcomes are the changes in pain severity and menstrual blood loss at 6 and 12 months compared with baseline.
Official title: Prospective Monocentric Interventional Study Evaluating the Efficacy and Safety of Radiofrequency Ablation (RFA) of Focal Uterine Adenomyosis Under Ultrasound Guidance
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
41
Start Date
2026-11-01
Completion Date
2029-03-31
Last Updated
2026-10-30
Healthy Volunteers
No
Conditions
Interventions
Myoblate Radiofrequency Ablation System (Mygen V-1000 generator)
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.
Locations (1)
University Hospital Pilsen
Pilsen, Czech Republic, Czechia