NCT05755958Active, not recruiting
Evaluation of the Efficacy of HIFU Treatment on Rectal Endometriosis Symptoms.
Doubled Blind Evaluation of the Efficacy of High Intensity Focused Ultrasound (HIFU) Treatment on Symptoms in Patients Treated for Rectal Endometriosis Compared to Sham.
Source: ClinicalTrials.gov · Last updated 5 Jun 2025
Brief summary (registry, in English)
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. In this comparative, randomized, double blind study , the primary objective is to evaluate the efficacy of the HIFU treatment of rectal endometriosis with Focal One® HIFU device on the Acute Pelvic Pain 3 months after HIFU treatment, in comparison to a Sham group.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 30 Jan 2023
- Start date
- 3 Feb 2023
- Primary completion date
- 23 Jan 2024
- Lead sponsor
- EDAP TMS S.A.
- Diseases
- Endometriosis
- NCT number
- NCT05755958
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 3 Feb 2023 to the primary completion date, 23 Jan 2024
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient with an implant located less than 1 cm from the treatment area,
- Patient who has already received HIFU treatment for a rectal endometriotic lesion,
Other illness
- Ongoing urogenital infection,
- History of segmental rectal resection or discoid resection,
- Inflammatory disease of the colon,
- Allergy to latex,
Other
- Anorectal anatomy incompatible with HIFU treatment,
- Overall pain level considered intolerable by the patient and making a potential 3-months delay management impossible,
- 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 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Prive de Provence Coordinator of this site? Confirm its status | Aix-en-Provence | France | Unknown status |
| CHU de Angers Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| Clinique Tivoli-Ducos Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| CHU Estaing Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| Hôpital du Kremlin Bicetre Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Unknown status |
| Hôpital Privé Le Bois Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Hôpital de la Croix Rousse Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Hôpital Cochin Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.