EDAP Concludes Phase 3 Study of HIFU Therapy To Treat Rectal Endometriosis

EDAP TMS SA, the worldwide innovator in automated energy-based treatments, reported that it has finished enlistment in its stage 3 review (Endo-HIFU-R2) assessing Central One Extreme focus Centered Ultrasound (HIFU) treatment for the treatment of profound penetrating rectal endometriosis. The continuous stage 3 review (NCT05755958) is a relative, randomized, twofold visually impaired preliminary, with the essential target of assessing intense pelvic torment levels in 60 patients.

Select treated patients are followed three months post-HIFU treatment in comparison to a sham group. The last patient was treated in January. Study results are expected in the second half of 2024, as per pharmabiz.

“We are pleased to announce the completion of enrollment in our phase 3 study, which represents a significant clinical milestone for our company,” said Ryan Rhodes, chief executive officer of EDAP TMS. “Considering the fact that the phase 3 study included a sham-controlled arm, we are highly encouraged by the robust pace of enrollment which we believe speaks to the strong interest from patients and physicians in exploring alternative treatment modalities beyond surgery. Rectal endometriosis is a painful and debilitating condition that impacts thousands of women each year with surgical intervention being the primary option beside medical treatment. By utilizing robotic HIFU, we hope to address this significant unmet need in women’s health by developing a safe and effective treatment option that is significantly less invasive than conventional surgical approaches. We would like to thank the patients and clinical investigators who participated in this clinical study, and we look forward to reporting results from the study later this year.”   

Rectal endometriosis actuates injuries related with agonizing side effects that can genuinely change personal satisfaction for some ladies. Central One HIFU is a harmless ablative strategy utilizing a focused energy ultrasound test to convey tissue devitalization through utilization of acoustic cavitation and warm removal.