NCT06195280

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

December 22, 2023

Last Update Submit

January 13, 2026

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

  • Correlation between the diagnosis of superficial endometriosis by the 3DT1 sequence in Magnetic Resonance Imaging and the histology obtained by laparoscopy

    The diagnostic validity of Magnetic resonance imaging compared to laparoscopy will be determined by correlation between the locations of the sites screened on Magnetic resonance imaging (Douglas cul de sac, vesicouterine cul de sac, right ovarian fossa, left ovarian fossa, right broad ligament, left broad ligament) and histologically confirmed endometriotic implants at these sites.

    between 30 and 150 days

Study Arms (1)

superficial endometriosis

EXPERIMENTAL

Endometriosis is a chronic, estrogen-dependent inflammatory disease secondary to tissue growth outside the uterine cavity, affecting approximately 10% of women of childbearing age.

Radiation: Magnetic resonance imaging, 3DT1 sequenceProcedure: Laparoscopy

Interventions

LaparoscopyPROCEDURE

After Magnetic Resonance Imaging, the patient will benefit from a laparoscopy under general anesthesia lasting an average of one hour.

superficial endometriosis
Magnetic resonance imaging, 3DT1 sequenceRADIATION

The patient will have an exploration pelvic Magnetic Resonance Imaging lasting approximately 15 to 20 minutes, without systematic injection of contrast product.

superficial endometriosis

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEndometriosis is a chronic, estrogen-dependent inflammatory disease secondary to tissue growth outside the uterine cavity, affecting approximately 10% of women of childbearing age.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Blomet

Paris, 75015, France

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Magnetic Resonance SpectroscopyLaparoscopy

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective, multicenter, non-randomized study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2023

First Posted

January 8, 2024

Study Start

April 1, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

January 15, 2026

Record last verified: 2026-01

Locations

FR(1)