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Evaluation of Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease
Sponsor: Assistance Publique Hopitaux De Marseille
Summary
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
Official title: Anatomopathological Evaluation of a New Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2024-11-30
Completion Date
2028-06-30
Last Updated
2024-08-30
Healthy Volunteers
No
Interventions
Echoguided transuterine vaginal biopsy performed before myomectomy or hysterectomy
Echoguided transuterine vaginal biopsy performed before myomectomy or hysterectomy