About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients over 18 years of age consulting at the hospital who require surgical management for uterine smooth muscle tumors (fibroma or TMM).
Able to give written consent
Beneficiary or beneficiary of a social security scheme
Disqualifiers
Person in a period of exclusion from another research protocol at the time consent is signed.
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.
Trial design
Single group
Treatments tested in this trial
Echoguided transuterine vaginal biopsy performed before myomectomy or hysterectomy
Procedure/SurgeryEchoguided transuterine vaginal biopsy performed before myomectomy or hysterectomy
Treatment groups
Trial outcomes
Primary outcomes
Validate an innovative, minimally invasive surgical technique for diagnosing uterine smooth muscle tumors by biopsy
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)
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: