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

Launched by ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE · Feb 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new and less invasive method called ultrasound-guided transuterine vaginal biopsy (ETVB) to help diagnose uterine fibroids and other related tumors. Uterine fibroids are non-cancerous growths in the uterus, but sometimes they can be confused with more serious tumors. The goal of this study is to see if this biopsy technique can provide an accurate diagnosis without needing major surgery. This could help prevent situations where patients either undergo unnecessary surgery or receive inappropriate treatment for a serious condition.

To participate in this trial, women aged 18 and older who are planning to have surgery for uterine tumors may be eligible. Participants will need to provide written consent and must be covered by a social security scheme. During the trial, participants can expect to have the ETVB procedure, which is designed to take a sample from the tumor for testing, allowing doctors to determine the best treatment. It’s important to note that certain individuals, such as pregnant women or those with specific legal or health conditions, cannot take part in this study. Overall, this trial aims to improve the way uterine tumors are diagnosed and managed, making treatment safer and more effective for women.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Patients over 18 years of age consulting the CHU de la Conception who require surgical treatment for uterine smooth muscle tumours (fibroma or TMM).
• • Able to give written consent
• • Beneficiary or beneficiary of a social security scheme
• Exclusion Criteria:
• • Person in a period of exclusion from another research protocol at the time of signing consent/no objection
• * Subjects covered by articles L1121-5 to 1121-8 of the Public Health Code, i.e. :
• • Pregnant women, women in labour 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.
• • A person who does not have a sufficient command of reading and understanding the French language to be able to consent to participate in the research.
• • 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 objectives of the research.