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Evaluation of the Efficacy of HIFU Treatment on Rectal Endometriosis Symptoms.
Sponsor: EDAP TMS S.A.
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
HIFU treatment in rectal Endometriosis
HIFU treatment of rectal endometriosis
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