An interventional study of Myoblate Radiofrequency Ablation System (Mygen V-1000 generator) in Adenomyosis and Adenomyoma of Uterus, sponsored by University Hospital Pilsen. Not yet recruiting at 1 site in Czechia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by University Hospital Pilsen · Not applicable, Interventional, and Treatment
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.
Adenomyosis is a benign uterine disease characterized by endometrial glands and stroma within the myometrium, causing heavy menstrual bleeding, dysmenorrhea and chronic pelvic pain. First-line treatment is hormonal and symptomatic; hysterectomy is the definitive treatment. Uterus-sparing thermal ablation (HIFU, microwave ablation, RFA) is a possible alternative, but the evidence for RFA comes mainly from small, often retrospective, monocentric series with short follow-up and limited use of validated patient-reported outcomes; data from the European population are limited.
Women with focal (circumscribed) adenomyosis confirmed by transvaginal ultrasound (TVUS; MUSA terminology) who fulfil the eligibility criteria are enrolled consecutively. Planned enrollment is approximately 41 participants to obtain 34 completed participants. Each participant undergoes transvaginal ultrasound-guided RFA of the lesion under general anesthesia. Use of the device in adenomyosis is off-label (the device is intended for ablation of uterine fibroids). Device settings follow the manufacturer's instructions for use and the operator's clinical judgement; procedure parameters are recorded for every participant.
The study uses a paired before/after design in which each participant's baseline status serves as the control. Follow-up visits take place at 3, 6 and 12 months (optionally 24 months) and include TVUS (lesion and uterine volume), VAS, PBAC and EQ-5D-5L. Questionnaires are completed electronically by the participant without assistance; EQ-5D-5L is completed on day 1-2 of the menstrual cycle at every visit. Adverse events are recorded from informed consent to the last visit and reported according to Regulation (EU) 2017/745 (MDR); periprocedural complications are graded by the Clavien-Dindo classification. Concomitant medication, initiation of hormonal therapy and reintervention are recorded and considered in sensitivity analyses.
Limitation: the single-arm open-label design cannot separate the treatment effect from regression to the mean and placebo effect.
140 studies on the registry are indexed under Adenomyosis; 52 are open to participants now.
This study's planned enrollment of 41 is below the median of 100 across 77 interventional studies indexed under Adenomyosis.
Browse Adenomyosis studies →University Hospital Pilsen is the lead sponsor of 10 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Transvaginal ultrasound-guided radiofrequency ablation of the focal adenomyotic lesion under general anesthesia using the Myoblate system (Mygen V-1000 generator). Follow-up visits with TVUS and questionnaires (VAS, PBAC, EQ-5D-5L) at 3, 6 and 12 months (optionally 24 months).
Device: 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.
Change in pain severity (VAS) from baseline
Pain severity measured by the Visual Analogue Scale (VAS), 0 (no pain) to 10 (worst imaginable pain); higher scores indicate worse pain. Paired comparison of the follow-up value with baseline.
Time frame: Baseline, 6 months and 12 months after the procedure
Change in menstrual blood loss (PBAC score) from baseline
Menstrual blood loss estimated by the Pictorial Blood Loss Assessment Chart (PBAC); higher scores indicate greater blood loss. Paired comparison of the follow-up value with baseline.
Time frame: Baseline, 6 months and 12 months after the procedure
Change in EQ VAS (EQ-5D-5L) from baseline
Self-rated health on the EQ-5D-5L visual analogue scale, 0 (worst imaginable health) to 100 (best imaginable health); questionnaire completed on day 1-2 of the menstrual cycle. Key secondary outcome.
Time frame: Baseline, 3, 6 and 12 months after the procedure (optionally 24 months)
Change in volume of the focal adenomyotic lesion and of the uterus on transvaginal ultrasound
Volume calculated by the ellipsoid formula V = 0.523 x D1 x D2 x D3 (three perpendicular diameters in cm); change from baseline.
Time frame: Baseline, 3, 6 and 12 months after the procedure (optionally 24 months)
Number of participants with adverse events and serious adverse events
Incidence, severity and relatedness (to the procedure and to the device) of adverse events and serious adverse events per Regulation (EU) 2017/745; periprocedural complications graded by the Clavien-Dindo classification.
Time frame: From signed informed consent to 12 months after the procedure (end of follow-up; optionally 24 months)
Patient satisfaction and perceived change after the procedure
Three single-item, non-validated questions: overall satisfaction with treatment result (5-point scale, 1 very dissatisfied to 5 very satisfied); change in overall condition compared with before the procedure (5-point scale, 1 much worse to 5 much better); willingness to undergo the procedure again (yes/no/unsure). Descriptive analysis only.
Time frame: 3, 6 and 12 months after the procedure (optionally 24 months)
Proportion of participants requiring repeat treatment of adenomyosis or hysterectomy
Proportion of participants requiring repeat treatment of adenomyosis or hysterectomy during follow-up.
Time frame: Up to 12 months after the procedure (optionally 24 months)
EQ-5D-5L index score and individual dimensions
EQ-5D-5L index (Czech value set) and the five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression); descriptive analysis only, without claim of statistical significance.
Time frame: Baseline, 3, 6 and 12 months after the procedure (optionally 24 months)
Duration of the ablation procedure
Duration of the procedure in minutes, recorded intraoperatively from the start to the end of the procedure.
Time frame: Day of procedure (intraoperative)
Initiation of hormonal therapy during follow-up
Number of participants who start hormonal therapy for adenomyosis during follow-up.
Time frame: Up to 12 months after the procedure (optionally 24 months)
Length of hospital stay after the procedure
Length of hospital stay in days, from the day of the procedure to discharge from hospital.
Time frame: From the procedure until hospital discharge, assessed up to 14 days
Time to return to usual activities
Time to return to usual activities in days, reported by the participant, from the day of the procedure until the participant reports resuming her usual daily activities.
Time frame: From the procedure up to 12 months
Plan to share: Undecided
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University Hospital Pilsen