Trial · NCT07906535
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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. |
| Other | Length of hospital stay after the procedure | From the procedure until hospital discharge, assessed up to 14 days | Length of hospital stay in days, from the day of the procedure to discharge from hospital. |
| Other | Time to return to usual activities | From the procedure up to 12 months | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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