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ACTIVE NOT RECRUITING
NCT05755958
NA

Evaluation of the Efficacy of HIFU Treatment on Rectal Endometriosis Symptoms.

Sponsor: EDAP TMS S.A.

View on ClinicalTrials.gov

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.

Official title: Doubled Blind Evaluation of the Efficacy of High Intensity Focused Ultrasound (HIFU) Treatment on Symptoms in Patients Treated for Rectal Endometriosis Compared to Sham.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-02-03

Completion Date

2025-07-31

Last Updated

2025-06-05

Healthy Volunteers

No

Conditions

Interventions

DEVICE

HIFU treatment in rectal Endometriosis

HIFU treatment of rectal endometriosis

DEVICE

SHAM HIFU procedure

SHAM HIFU procedure

Locations (9)

Hopital Privé de Provence

Aix-en-Provence, France

CHU de Angers

Angers, France

Clinique Tivoli-Ducos

Bordeaux, France

Chu Estaing

Clermont-Ferrand, France

Hôpital du Kremlin Bicetre

Le Kremlin-Bicêtre, France

Hôpital privé Le Bois

Lille, France

Hopital de la Croix Rousse

Lyon, France

Hôpital COCHIN

Paris, France

CHU Strasbourg

Strasbourg, France