New ultrasound-guided biopsy technique for uterine fibroids
Anatomopathological Evaluation of a New Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease
This study is testing a new ultrasound-guided biopsy method to see if it can improve the diagnosis of uterine fibroids for patients needing surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille) |
| Trial ID | NCT06845982 on ClinicalTrials.gov |
What this trial studies
This study evaluates a novel ultrasound-guided transuterine vaginal biopsy technique aimed at improving the diagnosis of uterine fibroids and related tumors. By providing a more accurate histological assessment, the technique seeks to reduce the risks of overtreatment and mismanagement associated with current imaging methods like MRI. Patients requiring surgical treatment for uterine smooth muscle tumors will be recruited for this intervention, which aims to enhance diagnostic precision and patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are seeking surgical treatment for uterine smooth muscle tumors.
Not a fit: Patients who are pregnant, nursing, or unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could lead to more accurate diagnoses and better treatment decisions for patients with uterine fibroids and tumors.
How similar studies have performed: While similar approaches have been explored, this specific technique is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Marseille
- Hopital Conception — Marseille, France (Recruiting)
Study contacts
- Study coordinator: Laura Miquel Dr
- Email: promotion.interne@ap-hm.fr
- Phone: +33491381927
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.