Actively Recruiting
Anatomopathological Evaluation of a New Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease
Led by Assistance Publique Hopitaux De Marseille · Updated on 2025-02-25
250
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Uterine fibroids are benign smooth muscle tumors of the uterus that are part of a broader group including malignant tumors with varying severity. Magnetic resonance imaging (MRI) is commonly used to differentiate fibroids from malignant tumors, but it has limitations that can lead to inappropriate treatment. This study aims to validate a new minimally invasive biopsy technique called ultrasound-guided transuterine vaginal biopsy (BVTE) to improve preoperative diagnosis and avoid unnecessary or harmful surgeries for uterine smooth muscle tumors. The procedure involves performing the BVTE under general anesthesia on the day scheduled for myomectomy or hysterectomy. The biopsy targets the center of the tumor via a transuterine route to reduce the risk of spreading cancer cells, taking 4 to 5 samples per tumor with a maximum of three tumors sampled. After the biopsy, patients undergo the planned surgery during the same operation, and all surgical specimens are sent for anatomopathological analysis. Participants will be assessed through anatomopathological comparison of the biopsy samples with the reference surgical specimens throughout the study period of 43 months. Researchers will monitor intraoperative and postoperative complications using the Clavien-Dindo classification. This study evaluates the feasibility, safety, and diagnostic accuracy of the BVTE technique as part of current clinical practice for women requiring surgical treatment for uterine smooth muscle tumors.
CONDITIONS
Brief Title
Anatomopathological Evaluation of a New Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years old needing surgical treatment for uterine smooth muscle tumors (fibroids or similar)
- Able to provide written consent
- Covered by a social security scheme
You will not qualify if you...
- Participating in another research protocol at the time of consent
- Pregnant, in labor, or breastfeeding
- Deprived of liberty by judicial or administrative decision
- Under psychiatric monitoring not covered by specific provisions
- Minors
- Adults under legal protection or unable to consent
- Insufficient understanding of French to provide consent
- Any condition that could compromise safety or study evaluation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo an ultrasound-guided transuterine vaginal biopsy under general anaesthetic followed by myomectomy or hysterectomy during the same operation. Samples are collected from uterine smooth muscle tumors for analysis.
1 surgical visit
Duration - Up to 43 months
Participants are monitored for intraoperative and postoperative complications and recovery after surgery.
Follow-up visits as scheduled until study end
Trial Site Locations
Total: 1 location
1
Hopital Conception
Marseille, France, 13005
Actively Recruiting
Research Team
L
Laura Miquel Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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