Status:
NOT_YET_RECRUITING
Evaluation of Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Fibroid
Uterine Corpus Smooth Muscle Neoplasm
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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...
Detailed Description
Fibroma is the most common uterine smooth muscle tumor. Women are symptomatic in 30% of cases. A large proportion of fibroids are asymptomatic and discovered on imaging. Surgical management is the onl...
Eligibility Criteria
Inclusion
- Patients over 18 years of age consulting at the hospital who require surgical management for uterine smooth muscle tumors (fibroma or TMM).
- Able to give written consent
- Beneficiary or beneficiary of a social security scheme
Exclusion
- Person in a period of exclusion from another research protocol at the time consent is signed.
- 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.
- A person who does not have a sufficient command of the French language to be able to give consent to participate in 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 research objectives.
Key Trial Info
Start Date :
November 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06576362
Start Date
November 30 2024
End Date
June 30 2028
Last Update
August 30 2024
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