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

NCT06576362 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2024-08-30

No results posted yet for this study

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

250 women will be included in this study within a periofd of inclusion of 36 months and their participation is estimated to 7 months Total study duration is 43 months

Conditions

  • Fibroid
  • Uterine Corpus Smooth Muscle Neoplasm

Interventions

PROCEDURE

Echoguided transuterine vaginal biopsy performed before myomectomy or hysterectomy

Echoguided transuterine vaginal biopsy performed before myomectomy or hysterectomy

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • Laura MIQUEL, Dr · Assistance Publique - Hôpitaux de marseille

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2028-06-30
Completion
2028-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06576362 on ClinicalTrials.gov