NCT06356831

Brief Summary

National multicentric registry of a cohort of patient with suffering parietal endometriosis, carried out by a multidisciplinary radiosurgery team

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
21mo left

Started Jun 2024

Typical duration for all trials

Geographic Reach
1 country

18 active sites

Status
recruiting

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

Study Progress52%
Jun 2024Jan 2028

First Submitted

Initial submission to the registry

March 19, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2024

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

3.1 years

First QC Date

March 19, 2024

Last Update Submit

November 26, 2025

Conditions

EndometriosisCryotherapy EffectSurgicalRadiology

Keywords

endometriosisCryo ablationSurgical operationradiology

Outcome Measures

Primary Outcomes (1)

  • creation of a national registry for the removal of nodules by cryoablation or surgery for parietal endometriosis

    number of Endometriosis 's patient treat by cryoablation or surgical

    at inclusion

Secondary Outcomes (15)

  • Characterize the epidemiology of parietal endometriosis nodules

    at 1 month, 6month 1year 2 years and 3 years after treatmeant

  • Characterize the epidemiology of parietal endometriosis nodules

    at inclusion

  • To assess the impact of hormone treatment on parietal endometriosis

    at 1 month, 6month 1year 2 years and 3 years after treatmeant

  • Assess the demographic distribution of parietal endometriosis

    At inclusion

  • Evaluate pre- and post-treatment imaging characteristics of parietal endometriosis

    through study completion average 3 years

  • +10 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient with endomecriosis at least 18 years of age who will be oer are treate by cryo ablation or surgical treatement

You may qualify if:

  • Presence of parietal endometriosis: with suggestive clinical and imaging criteria (MRI and ultrasound)
  • Symptomatic parietal endometriosis (VAS \> 3 OR bothersome bleeding OR reported impact on quality of life)

You may not qualify if:

  • Endometriosis not affecting the anterior wall of the abdomen (as deep pelvic muscle: ilio-psoas, obturators, perineal, ischio-anal fossa)
  • Minor patient (\< 18 years)
  • Pregnant patient at any trimester
  • Patient with hemostasis disorders (constitutional or acquired)
  • Patient with contraindications to MRI
  • Female patient with a planned medical or surgical procedure for the duration of the study that may interfere with the proper conduct of the study.
  • Patient unable to understand the information provided
  • Patient who is not affiliated to the social security system
  • Patient under curatorship or tutorship
  • Patient with a nodule of primary or secondary malignant tumor origin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

CHU bordeaux

Bordeau, France

RECRUITING

Clinique Tivoli

Bordeaux, France

RECRUITING

CHU Clermont Ferrand

Clermont-Ferrand, France

RECRUITING

CHI Creteil

Créteil, France

RECRUITING

Lyon Hôpital La Croix Rousse

Lyon, France

RECRUITING

Lyon Hôpital Sud

Lyon, France

RECRUITING

Lyon Louis Pradel

Lyon, France

ACTIVE NOT RECRUITING

APHM-Hôpital Nord

Marseille, France

ACTIVE NOT RECRUITING

APHP-Hôpital la Conception La Timone

Marseille, France

RECRUITING

CHU Montpellier

Montpellier, France

RECRUITING

CHU Nime

Nîmes, France

RECRUITING

AP-HP - Tenon

Paris, France

RECRUITING

AP-HP Hôpital Européen Georges Pompidou

Paris, France

RECRUITING

APHP Cochin-Port Royal

Paris, France

RECRUITING

APHP-La Pitié

Paris, France

RECRUITING

CHU Strasbourg

Strasbourg, France

ENROLLING BY INVITATION

CHU Toulouse

Toulouse, France

ACTIVE NOT RECRUITING

CH Valencienne

Valenciennes, France

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Léo RAZAKAMAMANTSOA

    CHIC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Léo Razakamanantsoa, Dr

CONTACT

0157023567Leo.Razakamanantsoa@chicreteil.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2024

First Posted

April 10, 2024

Study Start

June 15, 2024

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

January 31, 2028

Last Updated

November 28, 2025

Record last verified: 2025-11

Locations

FR(18)