Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT05755958
Eligibility Criteria:
Inclusion Criteria:
* Patient 18 years of age or older,
* Rectal endometriosis on preoperative imaging with no other digestive location,
* Symptomatic patient (Acute pelvic pain \> 3), in failure of drug treatment,
* Endometriotic lesion visible on ultrasound and confirmed on MRI,
* Centralized MRI, reviewed and validated by the MRI review committee,
* No current pregnancy and no pregnancy plan during the study period,
* Patient agreeing not to change her hormonal treatment throughout the study period,
* Patient accepting the constraints of follow-up defined in the framework of the study,
* Patient affiliated to French health insurance.
Exclusion Criteria:
* Ongoing urogenital infection,
* Anorectal anatomy incompatible with HIFU treatment,
* Overall pain level considered intolerable by the patient and making a potential 3-months delay management impossible,
* History of segmental rectal resection or discoid resection,
* Patient with an implant located less than 1 cm from the treatment area,
* Inflammatory disease of the colon,
* Allergy to latex,
* No scheduled endometriosis procedures during study follow-up,
* Treatment of endometriosis in the context of pregnancy desire for which a 3-month delay is not appropriate
* Patient with contraindications to MRI,
* Patient who has already received HIFU treatment for a rectal endometriotic lesion,
* Patient who does not speak or read French,
* Patient deprived of liberty following a judicial or administrative decision,
* Patient in labor or nursing,
* Patient under guardianship or curatorship
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05755958
Study Brief:
Protocol Section:
NCT05755958