NCT05755958

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.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: EDAP TMS S.A. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Endometriosis

Interventions

Type	Name	Description
DEVICE	HIFU treatment in rectal Endometriosis	HIFU treatment of rectal endometriosis
DEVICE	SHAM HIFU procedure	SHAM HIFU procedure

Timeline

• Start date: 2023-02-03
• Primary completion: 2024-01-23
• Completion: 2025-07-31
• First posted: 2023-03-06
• Last updated: 2025-06-05

Locations

9 sites across 1 country: France