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PROCEPT BioRobotics Completes Enrollment in WATER II Pivotal Clinical Trial

Truckee, CA (UroToday.com) PROCEPT BioRobotics, a Silicon Valley surgical robotics company developing novel and disruptive technologies to treat prostate disease, announced the completion of patient enrollment in the WATER II (Waterjet Ablation Therapy for Endoscopic Resection for prostate tissue) Study.  The WATER II Study is a U.S. investigational device exemption (IDE) clinical trial evaluating the safety and efficacy of Aquablation therapy, delivered by the company’s AquaBeam® System, in large prostates 80 to 150 milliliters (mL) in size for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).  

The WATER II study enrolled 101 patients at 16 sites in the U.S. and Canada.  The study is the company’s second Phase III pivotal study to complete enrollment in the past 12 months and is a follow-up to the WATER Study.  Results from the WATER Study, presented at the 2017 American Urological Association (AUA) Annual Meeting, showed a superior safety profile for Aquablation therapy with very strong efficacy outcomes comparable to the gold standard transurethral resection of the prostate (TURP) for the treatment of BPH.   
“Aquablation therapy demonstrated a significant clinical advantage over TURP in the WATER Study by providing predictable and reproducible outcomes regardless of the size of the prostate,” said Dr. Mihir Desai, Professor of Clinical Urology at Keck Hospital, University of Southern California in Los Angeles. “The results of WATER II will further validate the breadth of application of Aquablation therapy in the treatment of BPH.”
Nikolai Aljuri, Ph.D., PROCEPT BioRobotics chief executive officer and founder added, “The speed at which this study was enrolled is a remarkable achievement and an indication of the enthusiasm and genuine interest in the technology by the clinical sites and patients.  We are committed to providing robust clinical data in support of Aquablation therapy.  The strong results of the WATER Study, the WATER II Study, and our recent FDA De Novo grant position the company well for the global commercial launch of Aquablation therapy in 2018.”

On December 21, 2017, the FDA granted the De Novo request for the PROCEPT BioRobotics’ AquaBeam System for the resection and removal of prostate tissue in men suffering from LUTS due to BPH, making the device available for commercial use in the U.S.  The AquaBeam System is the first FDA granted surgical robot providing autonomous tissue removal for the treatment of BPH.  It combines real-time, multi-dimensional prostate imaging and surgical robotics to deliver Aquablation therapy, waterjet ablation that enables targeted, controlled, heat-free and immediate removal of prostate tissue. 

The AquaBeam System is commercially available in Canada, Australia, New Zealand and select European markets. In the U.S., the device will be commercially available in early 2018.