Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis
- Conditions
- Endometriosis, Rectum
- Interventions
- Device: HIFU treatment
- Registration Number
- NCT04494568
- Lead Sponsor
- EDAP TMS S.A.
- 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-intensity ultrasound probe to induce tissue devitalization using acoustic cavitation and thermal ablation. Focal One® is a transrectal HIFU device, which is validated to treat prostatic cancer.
The primary objective of this clinical investigation is to evaluate the safety of the HIFU treatment of rectal endometriosis with Focal One® HIFU device.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HIFU intervention HIFU treatment patients will benefit of an HIFU Treatment of their rectal endometriosis
- Primary Outcome Measures
Name Time Method Evaluate the tolerance of rectal endometriosis treatment with HIFU 6 months The tolerance of the treatment will be evaluated by the analysis of adverse events occurrence at 6 months post-HIFU treatment
- Secondary Outcome Measures
Name Time Method Evaluation of the of quality of life evolution of patients after HIFU treatment at 1 month, 3 months and 6 months post-intervention, Quality of life questionnaire : MOS- SF-36
Evaluation of the evolution of the nodule's volume at 6 months The pre- and post-treatment comparison of the volume of the endometriodsis nodule measurement.
Evaluation of the post-intervention analgesic treatment during the fisrt 10 days post treatment. The level of medication during the fisrt 10 days post treatment will be studied by analysing the data collected in patient book.
Evaluation of the sexual symptoms evolution of patients after HIFU treatment at 1 month, 3 months and 6 months post-intervention SFSI questionnaire
Evaluation of the gynecological symptoms evolution of patients after HIFU treatment at 1 month, 3 months and 6 months post-intervention EVA symptom Questionnaires
Evaluation of the digestive symptoms evolution of patients after HIFU treatment at 1 month, 3 months and 6 months post-intervention Kess questionnaires
Evaluation of the urinary symptoms evolution of patients after HIFU treatment at 1 month, 3 months and 6 months post-intervention USP questionnaire
Trial Locations
- Locations (5)
Clinique Tivoli-Ducos
🇫🇷Bordeaux, France
CHU de Angers
🇫🇷Angers, France
Hôpital BICETRE
🇫🇷Le Kremlin-Bicêtre, France
Clinique de Gynécologie
🇫🇷Lille, France
Hopital de la Croix Rousse
🇫🇷Lyon, France