PROCEPT BioRobotics announced today that the first patients were treated in its WATER II Study, a clinical trial testing the safety and efficacy of Aquablation delivery by its surgical robotic AquaBeam System to treat benign prostatic hyperplasia.

The trials test the use of the system in prostates 80 to150 mL and will enroll 100 patients at up to 20 sites in the U.S. and Canada.

“Prostates greater than 80 mL provide an increased level of surgical complexity. The AquaBeam System provides intra-operative image guidance that allows the surgeon to develop an optimal tissue removal plan followed by the precision of a robotically executed waterjet,” co-principal investigator Dr. Mihir Desai of Keck Hospital, University of Southern California said in the press release. “Aquablation has the potential to standardize treatment and deliver predictable and reproducible results regardless of the size of the prostate.”

Using prostate imaging and surgical robotics, the AquaBeam System delivers the waterjet ablation therapy in a way meant to enable immediate removal of prostate tissue in order to treat lower urinary tract symptoms caused by BPH. The system’s intra-procedural ultrasound imaging provides real-time surgical planning and mapping so that the therapy is targeted at a defined area.

This latest study follows the WATER Study, which showed Aquablation by the the AquaBeam System resulted in similar outcomes to transurethral resection of the prostate for treatment of BPH in prostates 30 to 80 mL.

“Aquablation is a promising technology for patients with BPH, offering a minimally invasive alternative to open prostatectomy,” Dr. Mohamed Bidair, who initiated trials at Sharp Grossmont Hospital in San Diego, said in the statement. “We are encouraged by the results of the WATER Study and look forward to exploring the potential benefits of this treatment option for those with larger prostates, a very common condition in older men that heretofore required open surgical intervention with a prolonged postoperative recovery course.”

According to the American Urological Association, open prostatectomy is usually performed on patients with prostates greater than 80 to100 mL, but with a large risk of blood loss, transfusion and longer hospital stays. Thus far, transurethral enucleation has not been widely used on such patients, but PROCEPT’s technology could provide an alternative solution.

“The WATER Study was able to demonstrate that Aquablation achieves superior safety and efficacy results in men with larger glands,” said Dr. Claus Roehrborn, co-principal investigator and chair of the Department of Urology at University of Texas Southwestern. “The WATER II study has been designed to further validate those results in prostates up to 150 milliliters in volume where current surgical options are more limited.”