Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis

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. The primary objective of this clinical investigation is to evaluate the safety of the HIFU treatment of rectal endometriosis with Focal One® HIFU device.