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Study identifier: NCT06845982 Synced from ClinicalTrials.gov · July 28, 2026
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Anatomopathological Evaluation of a New Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease

Condition: Uterine Fibroids (UF)  ·  Sponsor: Assistance Publique Hopitaux De Marseille

PhaseNA
Planned participants250
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this study

The benign uterine fibroid is part of the broader term uterine smooth muscle tumour, which also includes malignant myometrial tumours (MSTs) of varying malignancy (uterine sarcoma, cellular fibroid, STUMP (uterine smooth muscle tumours of uncertain malignant potential)). Magnetic resonance imaging (MRI) is the most effective test for distinguishing a fibroid from a TMM, but its reliability is limited. This leads to inappropriate management in a number of situations. The first is the risk of overtreatment by performing surgery for a suspected TMM on MRI in a patient with few or no symptoms and a final histological diagnosis of fibroid. The second is the risk of unsatisfactory or even harmful cancer surgical treatment in a symptomatic patient with a reassuring MRI diagnosis but a final histological diagnosis of TMM. Finally, there is the possibility of treating a lesion labelled as a fibroid on MRI with an alternative technique (embolisation, radiofrequency, HIFU) when it is in fact a TMM, thereby delaying appropriate treatment and worsening the prognosis. Ultrasound-guided transuterine vaginal biopsy (ETVB) is an innovative and promising minimally invasive technique for preoperative anatomopathological diagnosis. It would make it possible to obtain a histological diagnosis without the need for surgery, thereby avoiding the inappropriate management described above. The aim of this study is to validate an innovative minimally invasive surgical technique (BVTE) for the diagnos…

This description comes directly from the study's public registry record.

Talk to the study team

Laura Miquel Dr  ·  +33491381927  ·  promotion.interne@ap-hm.fr

Always discuss trial participation with your own doctor first.

Locations (1)

Hopital ConceptionMarseille, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT06845982