Status:

NOT_YET_RECRUITING

SUPerficial ENDometriosis In Magnetic Resonance Imaging

Lead Sponsor:

GCS Ramsay Santé pour l'Enseignement et la Recherche

Collaborating Sponsors:

Euraxi Pharma

Conditions:

Endometriosis

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief Summary

The purpose of the study is to determine the correlation between the diagnosis of Superficial endometriosis by the 3DT1 sequence on Magnetic resonance imaging and the histology obtained by laparoscopy...

Detailed Description

This is a prospective, multicenter, non-randomized study evaluating the diagnostic performance of Magnetic Resonance Imaging in superficial endometriosis. The duration of the patient's participation ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria :
  • Age ≥ 18 years;
  • Non-menopausal patient;
  • Patient scheduled for exploratory laparoscopy;
  • Patient requiring a preoperative pelvic MRI
  • Patient having been informed and having signed an informed consent form.
  • Exclusion Criteria :
  • Classic contraindications to magnetic resonance imaging;
  • Contraindications to anesthesia for exploratory laparoscopy;
  • Contraindication to surgery following the findings of magnetic resonance imaging results;
  • Patient with endometrioma \> 4 cm;
  • Patient with known deep endometriosis;
  • Patient uncooperative with protocol requirements or unable to attend the center for scheduled visits;
  • Pregnant woman or woman of childbearing age, without effective contraception or breastfeeding;
  • Patient participating in another clinical trial, or during a period of exclusion from another clinical trial;
  • Patient under guardianship, under curatorship or subject to legal protection, persons deprived of liberty by a judicial or administrative decision, persons subject to psychiatric care and admitted to a health or social establishment;
  • Patient not beneficiary of a social security system
  • Patient under State Medical Aid.

Exclusion

    Key Trial Info

    Start Date :

    April 1 2025

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    March 1 2026

    Estimated Enrollment :

    112 Patients enrolled

    Trial Details

    Trial ID

    NCT06195280

    Start Date

    April 1 2025

    End Date

    March 1 2026

    Last Update

    March 27 2025

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Clinique Blomet

    Paris, France, 75015