Long-term HIFU treatment for rectal endometriosis
Evaluation of the Long-term Therapeutic Effect of High-Intensity Focused Ultrasound (HIFU) Treatment in Patients With Rectal Endometriosis
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 |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Edap Tms S.a. Industry-sponsored |
| Locations | 1 site (Lyon) |
| Trial ID | NCT07179419 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: HIFU has shown promise in small and early studies for pelvic indications, but long-term data specifically for rectal endometriosis remain limited.
Eligibility criteria
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 this trial is running
Lyon
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.