Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis

Conditions
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Endometriosis, Rectum

Intervention / Treatment
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* Device: HIFU treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: INTERVENTIONAL, PROSPECTIVE, MULTICENTRIC, NON-RANDOMIZED AND NON-CONROLLED STUDY
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIFU intervention<br>patients will benefit of an HIFU Treatment of their rectal endometriosis | Device: HIFU treatment<br>* HIFU Treatment of rectal endometriosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the tolerance of rectal endometriosis treatment with HIFU | The tolerance of the treatment will be evaluated by the analysis of adverse events occurrence at 6 months post-HIFU treatment | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the gynecological symptoms evolution of patients after HIFU treatment | EVA symptom Questionnaires | at 1 month, 3 months and 6 months post-intervention | 
| Evaluation of the of quality of life evolution of patients after HIFU treatment | Quality of life questionnaire : MOS- SF-36 | at 1 month, 3 months and 6 months post-intervention, | 
| Evaluation of the evolution of the nodule's volume | The pre- and post-treatment comparison of the volume of the endometriodsis nodule measurement. | at 6 months | 
| Evaluation of the post-intervention analgesic treatment | The level of medication during the fisrt 10 days post treatment will be studied by analysing the data collected in patient book. | during the fisrt 10 days post treatment. | 
| Evaluation of the digestive symptoms evolution of patients after HIFU treatment | Wexner | at 1 month, 3 months and 6 months post-intervention | 
| Evaluation of the digestive symptoms evolution of patients after HIFU treatment | Kess questionnaires | at 1 month, 3 months and 6 months post-intervention | 
| Evaluation of the sexual symptoms evolution of patients after HIFU treatment | SFSI questionnaire | at 1 month, 3 months and 6 months post-intervention | 
| Evaluation of the urinary symptoms evolution of patients after HIFU treatment | USP questionnaire | at 1 month, 3 months and 6 months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rectal endometriosis, HIFU