Key Points
- The new study is using EDAP’s robotic focused ultrasound system to treat benign prostatic hyperplasia (BPH).
- The prospective, multicenter clinical trial will initially take place at two leading prostate treatment centers in France.
EDAP TMS has announced the start of a new study exploring the use of their Focal One® robotic high-intensity focused ultrasound (HIFU) device for the treatment of benign prostatic hyperplasia (BPH). BPH, or prostate enlargement, is a noncancerous condition that commonly causes lower urinary tract symptoms in men.
The two-part, prospective, multicenter clinical trial (NCT06601179) will initially take place at two leading prostate treatment centers in France. Phase 1 of the study will enroll 10 participants to help define the optimal treatment parameters to effectively treat BPH and its related symptoms with minimal side effects. If there are no serious adverse events reported after three months, researchers will begin Phase 2, when the study will expand patient enrollment across a larger number of treatment centers to validate the safety and efficacy of the parameters as defined in Phase 1. Up to 90 participants will be enrolled in Phase 2. In all, participants will be followed for three years.
“We are excited to initiate this important clinical study evaluating Focal One robotic HIFU for the treatment of BPH, a condition that impacts millions of men each year,” said Ryan Rhodes, CEO of EDAP TMS, in a press release. “While there are other treatment options available for treating BPH, there remains a significant need for much less invasive treatment approaches that can preserve and protect the integrity of the urethra and other critical structures. We believe Focal One is ideally positioned to deliver this type of treatment solution, and this clinical approach in addressing BPH represents a logical next step in expanding our technology beyond the application in prostate cancer. We also believe this study will serve as a foundation for initiating a BPH clinical study in the United States next year.”
The company has a long history of treating prostate cancer. EDAP has two devices that have received regulatory clearance in the US, Europe, Canada, Korea, Brazil, and other countries to treat the prostate. In the US, both devices are indicated for the ablation of prostate tissue, which could include benign or malignant tissue. Earlier this year, the company’s Focal One device was also granted Breakthrough Device Designation by the US Food and Drug Administration for treating deep infiltrating rectal endometriosis.