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

NCT06576362 | Not Yet Recruiting

• 2 other identifiers: RCAPHM23-03872024-A01337-40
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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 to evaluate complications relating to the the technique and its potential adverse events. Participants presenting at hospital patients presenting a surgical indication for myomectomy or hysterectomy during the inclusion period will be offered the study. Preoperatively, women will undergo the following two examinations:

1. 1.A pelvic MRI, the characteristics of which will be analyzed by the expert women\'s imaging team.
2. 2.A BVTE under general anaesthetic in the operating theatre on the day of the planned myomectomy or hysterectomy.

Conditions

Fibroid; Uterine Corpus Smooth Muscle Neoplasm

Keywords

TMM; BVTE; diagnosis; Vaginal biopsy; echo-guided transuterine vaginal biopsy; myomectomy; hysterectomy

Outcome Measures

Primary Outcomes (1)

• Validate an innovative, minimally invasive surgical technique for diagnosing uterine smooth muscle tumors by biopsy

  Estimate the anatomopathological sensitivity of BVTE, with its 95% confidence interval, by comparing it with the reference technique, i.e. anatomopathological diagnosis on surgical specimens, to ensure a low number of false negatives (fibroid diagnosis on BVTE with final diagnosis of TMM)

  From enrollment before surgery to the follow-up visit 3 months after surgery

Study Arms (1)

Echoguided transuterine vaginal biopsy

EXPERIMENTAL

Echoguided transuterine vaginal biopsy on women presenting to hospital with a surgical indication for myomectomy or hysterectomy

Procedure: Echoguided transuterine vaginal biopsy performed before myomectomy or hysterectomy

Interventions

Echoguided transuterine vaginal biopsy performed before myomectomy or hysterectomy PROCEDURE

Echoguided transuterine vaginal biopsy performed before myomectomy or hysterectomy

Echoguided transuterine vaginal biopsy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women over 18 years of age consulting at the hospital, who require surgical management for uterine smooth muscle tumors (fibroma or TMM).
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

MeSH Terms

Conditions

Leiomyoma; Disease

Interventions

Hysterectomy

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Laura MIQUEL, Dr

  Assistance Publique - Hôpitaux de marseille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Miquel, Dr

CONTACT

0491382747; laura.miquel@ap-hm.fr

Franceline Cartier, MSc

CONTACT

0491381927; promotion.interne@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective diagnostic study vs. reference technique

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: November 30, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share