Evaluation of Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease

Launched by ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE · Aug 27, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new, less invasive way to diagnose uterine tumors, specifically fibroids, in women aged 18 and older. The researchers want to see how effective this ultrasound-guided biopsy technique is, as well as any potential complications that might arise from it. Women who are scheduled for surgery to remove fibroids or their uterus will be invited to participate in the study. Before the biopsy, they'll have a pelvic MRI to help assess their condition.

To join the study, women must be over 18 years old, able to give written consent, and have a valid social security plan. Women who are pregnant, nursing, or have certain medical or legal restrictions cannot participate. The study will include 250 women over about 36 months, with each participant's involvement lasting around 7 months. This trial is important because it could improve how doctors diagnose uterine tumors while minimizing risks for patients.

Gender

FEMALE

Eligibility criteria

• 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.