Registry for treating parietal endometriosis with cryoablation and surgery

National Registry of Surgical Treatment and Percutaneous Cryoablation of Parietal Endometriosis

This study is tracking how well cryoablation and surgery work for people with parietal endometriosis over three years.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Centre Hospitalier Intercommunal Creteil (other)
• Locations: 18 sites (Bordeau and 17 other locations)
• Trial ID: NCT06356831 on ClinicalTrials.gov

What this trial studies

This national multicentric registry collects data on patients suffering from parietal endometriosis who are treated with cryoablation or surgical interventions. The registry aims to follow these patients for three years post-treatment to assess outcomes and effectiveness. A multidisciplinary radiosurgery team will oversee the data collection and patient management, ensuring comprehensive care and monitoring.

Who should consider this trial

Good fit: Ideal candidates are women with symptomatic parietal endometriosis confirmed by clinical and imaging criteria.

Not a fit: Patients with endometriosis not affecting the anterior abdominal wall or those with contraindications to MRI will not benefit from this study.

Why it matters

Potential benefit: If successful, this registry could improve treatment strategies and outcomes for patients with parietal endometriosis.

How similar studies have performed: While similar approaches have been utilized in other studies, this specific registry for parietal endometriosis treatment is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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 systemic infection or localized scar infection upon inclusion.
* 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

Where this trial is running

Bordeau and 17 other locations

• 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)

Study contacts

• Principal investigator: Léo RAZAKAMAMANTSOA — CHIC
• Study coordinator: Léo Razakamanantsoa, Dr

Conditions: Endometriosis, Cryotherapy Effect, Surgical, Radiology, endometriosis, Cryo ablation, Surgical operation, radiology