Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL
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.
Brief 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.