Long-term HIFU treatment for rectal endometriosis
Official title: Evaluation of the Long-term Therapeutic Effect of High-Intensity Focused Ultrasound (HIFU) Treatment in Patients With Rectal Endometriosis
Run by Edap Tms S.a. · NCT07179419 · Data updated 2026-11-12
See if high-intensity focused ultrasound (HIFU) provides lasting symptom relief for people who had rectal endometriosis treated with HIFU.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 140 (estimated) |
| Sponsor | Edap Tms S.a. Industry-sponsored |
| Locations | 1 site (Lyon) |
| Status | Recruiting |
| Started | October 10, 2021 |
| Main results expected | September 30, 2029 |
| Study ends | September 30, 2029 |
| Registry record updated | September 17, 2025 |
| Trial ID | NCT07179419 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people who received HIFU for rectal endometriosis in study HIFU/F/13.12, HIFU/F/20.01 (ENDO HIFU R1), or HIFU/F/21.12 (ENDO HIFU R2), agree to participate, and have internet access to complete electronic questionnaires.
✕Probably not a fit
Patients who were not treated with HIFU in the listed prior studies, who cannot complete electronic questionnaires, or who are under guardianship or deprived of liberty are not eligible and therefore will not receive benefit from this follow-up.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational follow-up collects long-term outcome data from patients previously treated with HIFU for rectal endometriosis in the named earlier HIFU studies. Participants complete an electronic questionnaire and receive a telephone call to report symptoms and other health parameters. No new procedures are performed; the study relies on patient-reported outcomes and phone monitoring. The goal is to describe durability of symptom change and any late effects after HIFU treatment.
Why it matters
Potential benefit: If successful, the study could show that HIFU provides durable symptom relief and lower recurrence for rectal endometriosis patients treated with this technique.
How similar studies have gone: HIFU has shown promise in small and early studies for pelvic indications, but long-term data specifically for rectal endometriosis remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who have been treated with HIFU for rectal endometriosis included in study HIFU/F/13.12, study HIFU/F/20.01 (ENDO HIFU R1) or study HIFU/F/21.12 (ENDO HIFU R2) * Agreeing to participate in the study * Patients with internet access so that they can complete the questionnaires electronically. Exclusion Criteria: * Patients deprived of their liberty following a judicial or administrative decision, * Patients under guardianship or conservatorship.
Where it's running
-
Hopital de la Croix Rousse
Lyon, France Recruiting
Study contacts
- Study coordinator: Djamila BENNAT
- Email: affaires-cliniques@edap-tms.com
- Phone: +33 472 153 125
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.