Trial · NCT07906535
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
NCT07906535, Not applicable, Not yet recruiting, University Hospital Pilsen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis. Trials, record NCT07906535. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07906535
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
- NCT number
- NCT07906535
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 41 participants, estimated
- Lead sponsor
- University Hospital Pilsen
- Conditions
- Adenomyosis, Adenomyoma of Uterus
- Interventions
- Myoblate Radiofrequency Ablation System (Mygen V-1000 generator)
- First posted
- 2026-10-30
- Last updated
- 2026-10-30
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in pain severity (VAS) from baseline | 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. |
| Primary | Change in menstrual blood loss (PBAC score) from baseline | 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. |
| Secondary | Change in EQ VAS (EQ-5D-5L) from baseline | Baseline, 3, 6 and 12 months after the procedure (optionally 24 months) | 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. |
| Secondary | Change in volume of the focal adenomyotic lesion and of the uterus on transvaginal ultrasound | Baseline, 3, 6 and 12 months after the procedure (optionally 24 months) | Volume calculated by the ellipsoid formula V = 0.523 x D1 x D2 x D3 (three perpendicular diameters in cm); change from baseline. |
| Secondary | Number of participants with adverse events and serious adverse events | From signed informed consent to 12 months after the procedure (end of follow-up; optionally 24 months) | 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. |
| Secondary | Patient satisfaction and perceived change after the procedure | 3, 6 and 12 months after the procedure (optionally 24 months) | 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. |
| Secondary | Proportion of participants requiring repeat treatment of adenomyosis or hysterectomy | Up to 12 months after the procedure (optionally 24 months) | Proportion of participants requiring repeat treatment of adenomyosis or hysterectomy during follow-up. |
| Other | EQ-5D-5L index score and individual dimensions | Baseline, 3, 6 and 12 months after the procedure (optionally 24 months) | 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. |
| Other | Duration of the ablation procedure | Day of procedure (intraoperative) | Duration of the procedure in minutes, recorded intraoperatively from the start to the end of the procedure. |
| Other | Initiation of hormonal therapy during follow-up | Up to 12 months after the procedure (optionally 24 months) | Number of participants who start hormonal therapy for adenomyosis during follow-up. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07906535
GET https://conductscience.org/api/trials/v1/NCT07906535/registered