Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis (NCT04494568) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis
France60 participantsStarted 2020-08-27
Plain-language 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.
Who can participate
Age range
25 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Gadolini…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate the tolerance of rectal endometriosis treatment with HIFU