AdenomyosisRFA-ADENO-USGNCT07906535
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
A study testing Myoblate Radiofrequency Ablation System (Mygen V-1000 generator) in people with Adenomyosis and Adenomyoma of Uterus, run by University Hospital Pilsen at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adenomyosis, Adenomyoma of Uterus
- What is being tested?
- Myoblate Radiofrequency Ablation System (Mygen V-1000 generator)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Nov 2026to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site
University Hospital Pilsen
Pilsen, Czech Republic, 32300
Jan Humplik, MD, +420 377 105 254, humplikj@fnplzen.cz
Jan Humplik, MD
About this study
Official title: Prospective Monocentric Interventional Study Evaluating the Efficacy and Safety of Radiofrequency Ablation (RFA) of Focal Uterine Adenomyosis Under Ultrasound Guidance
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.
Read the detailed description
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.
- Conditions
- Adenomyosis, Adenomyoma of Uterus
- Being tested
- Myoblate Radiofrequency Ablation System (Mygen V-1000 generator)
- Keywords
- Adenomyosis, Focal adenomyosis, Radiofrequency ablation, Ultrasound-guided, Transvaginal ultrasound, Uterus-sparing treatment, Dysmenorrhea, Heavy menstrual bleeding
- Medical subject headings
- Adenomyosis, Dysmenorrhea, Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| RFA of focal adenomyosis | Experimental | 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). Receives: Device: Myoblate Radiofrequency Ablation System (Mygen V-1000 generator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 6 months and 12 months after the procedure
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months after the procedure (optionally 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, open-label, paired before/after evaluation; each participant's baseline status serves as the control. Follow-up at 3, 6 and 12 months (optionally 24 months).
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Pilsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906535
- Sponsor's protocol ID
- RFA-ADENO-USG
- Acronym
- RFA-ADENO-USG
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Monocentric Interventional Study Evaluating the Efficacy and Safety of Radiofrequency Ablation (RFA) of Focal Uterine Adenomyosis Under Ultrasound Guidance
- ClinicalTrials.gov ID
- NCT07906535
- Acronym / sponsor ID
- RFA-ADENO-USG / RFA-ADENO-USG
- Conditions
- Adenomyosis, Adenomyoma of Uterus
- Keywords
- Adenomyosis, Focal adenomyosis, Radiofrequency ablation, Ultrasound-guided, Transvaginal ultrasound, Uterus-sparing treatment, Dysmenorrhea, Heavy menstrual bleeding
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- University Hospital PilsenUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, open-label, paired before/after evaluation; each participant's baseline status serves as the control. Follow-up at 3, 6 and 12 months (optionally 24 months).
| Arm | Type | Receives |
|---|---|---|
| RFA of focal adenomyosis | Experimental | Device: Myoblate Radiofrequency Ablation System (Mygen V-1000 generator)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | RFA of focal adenomyosis |
Primary outcome
Change in pain severity (VAS) from baseline
Time frame: Baseline, 6 months and 12 months after the procedure
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.
Change in menstrual blood loss (PBAC score) from baseline
Time frame: Baseline, 6 months and 12 months after the procedure
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.
5 secondary outcomes
Change in EQ VAS (EQ-5D-5L) from baseline
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
Time frame: Baseline, 3, 6 and 12 months after the procedure (optionally 24 months)
Number of participants with adverse events and serious adverse events
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
Time frame: 3, 6 and 12 months after the procedure (optionally 24 months)
Proportion of participants requiring repeat treatment of adenomyosis or hysterectomy
Time frame: Up to 12 months after the procedure (optionally 24 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myoblate Radiofrequency Ablation System (Mygen V-1000 generator) in people with Adenomyosis and Adenomyoma of Uterus, run by University Hospital Pilsen at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Humplík, MD (+420 377 105 254, humplikj@fnplzen.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain severity (VAS) from baseline (time frame: Baseline, 6 months and 12 months after the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.