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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05755958
Study type Interventional
Source EDAP TMS S.A.
Contact
Status Active, not recruiting
Phase N/A
Start date February 3, 2023
Completion date December 31, 2024

See also
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