Clinical trial · Interventional
Evaluation of Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease
Anatomopathological Evaluation of a New Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this diagnostic, prospective study is to evaluate an innovative, minimally invasive surgical technique for diagnosing uterine smooth muscle tumors by biopsy, in women aged 18 and more, and to evaluate complications relating to the the technique and its potential adverse events. Participants presenting at hospital patients presenting a surgical indication for myomectomy or hysterectomy during the inclusion period will be offered the study. Preoperatively, women will undergo the following two examinations: 1. A pelvic MRI, the characteristics of which will be analyzed by the expert women\'s imaging team. 2. A BVTE under general anaesthetic in the operating theatre on the day of the planned myomectomy or hysterectomy. 250 women will be included in this study within a periofd of inclusion of 36 months and their participation is estimated to 7 months Total study duration is 43 months
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibroid | Leiomyoma | ALIAS | 0.90 |
| Uterine Corpus Smooth Muscle Neoplasm | Uterine Corpus Smooth Muscle Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Echoguided transuterine vaginal biopsy performed before myomectomy or hysterectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Echoguided transuterine vaginal biopsy
- description
- Echoguided transuterine vaginal biopsy on women presenting to hospital with a surgical indication for myomectomy or hysterectomy
- interventionNames
- Procedure: Echoguided transuterine vaginal biopsy performed before myomectomy or hysterectomy
Primary outcomes (1)
- measure
- Validate an innovative, minimally invasive surgical technique for diagnosing uterine smooth muscle tumors by biopsy
- timeFrame
- From enrollment before surgery to the follow-up visit 3 months after surgery
- description
- Estimate the anatomopathological sensitivity of BVTE, with its 95% confidence interval, by comparing it with the reference technique, i.e. anatomopathological diagnosis on surgical specimens, to ensure a low number of false negatives (fibroid diagnosis on BVTE with final diagnosis of TMM)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients over 18 years of age consulting at the hospital who require surgical management for uterine smooth muscle tumors (fibroma or TMM). 2. Able to give written consent 3. Beneficiary or beneficiary of a social security scheme Exclusion Criteria: 1. Person in a period of exclusion from another research protocol at the time consent is signed. 2. Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code, i.e. : * Pregnant women, parturients and nursing mothers * Persons deprived of their liberty by judicial or administrative decision * Persons subject to psychiatric monitoring under articles L3112-1 and L3113-1 who are not covered by the provisions of article L1121-8. * Minors * Adults subject to a legal protection measure or unable to express their consent. 3. A person who does not have a sufficient command of the French language to be able to give consent to participate in research. 4. Any other reason which, in the opinion of the investigator, could compromise the safety of the research participant and/or interfere with the evaluation of the research objectives.
References
Publications (0)
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