Status:
COMPLETED
Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis
Lead Sponsor:
EDAP TMS S.A.
Conditions:
Endometriosis, Rectum
Eligibility:
FEMALE
25+ years
Phase:
NA
Brief Summary
Rectal endometriosis (RE) induces lesions associated with painful symptoms that can alter quality of life. High Intensity Focused Ultrasound (HIFU) is a non-invasive ablative procedure using a high-in...
Eligibility Criteria
Inclusion
- Patients aged at least 25 years-old
- Rectal endometriosis in preoperative imaging, without other digestive locations (colon, ileum and small intentine)
- Symptomatic patient refusing hormonal treatment and/or surgery.
- Endometriosic nodule visible on echography with contrast and confirmed in Gadolinium MRI and difusion sequence (according to standardized protocol)
- Nodule with intrarectal protrusion of less than 50% (allowing the positioning of the probe in front of the rectal nodule)
- Distance from the upper pole to the anal margin ≤ 15 cm (measurement by MRI with intra-rectal contrast)
- No curent pregnancy (negative BHCG \<72h before the HIFU procedure) and no pregnancy project within 6 months after the HIFU procedure (post-treatment MRI delay)
- Patient agreeing not to change her hormone treatment for the duration of the study.
- Patient accepting the study constraints
- Health insurance affiliated patient or beneficiary of an equivalent coverage
Exclusion
- Virgin patient
- Ongoing uro-genital infection
- Anorectal anatomy incompatible with HIFU therapy
- History of segmental rectal resection with mechanical anastomosis, shaving or discoid resection
- Patient with an implant within 1cm of the treatment area (stent, catheter, ESSURE® contraceptive implants).
- Inflammatory colon disease (ulcerative colitis, Crohn's disease and others)
- Latex allergy
- Patient with contraindications to MRI
- Patient with contraindications to Gadolinium injection
- Patient previously treated with HIFU for a rectal endometriotic lesion
- Patient not speaking nor reading French
- Patient deprived of liberty following a legal or administrative decision
- Patient under guardianship or tutelage measure
Key Trial Info
Start Date :
August 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04494568
Start Date
August 27 2020
End Date
November 30 2022
Last Update
February 1 2023
Active Locations (5)
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1
CHU de Angers
Angers, France
2
Clinique Tivoli-Ducos
Bordeaux, France
3
Hôpital BICETRE
Le Kremlin-Bicêtre, France
4
Clinique de Gynécologie
Lille, France