Procept BioRobotics launches AquaBeam trial

Procept BioRobotics said today it treated the 1st patients in a clinical trial of its AquaBeam water ablation therapy system designed to treat prostate disease.

The Water study is a phase III clinical study evaluating the safety and effectiveness of the system compared to transurethral resection of the prostate, the current standard of care for treating prostate disease.

“Despite the advances with laser technology, TURP is still the most common procedure worldwide for the treatment of lower urinary tract symptoms, and while it has demonstrated durable results, it does come with certain risks affecting sexual function, ejaculation, and incontinence problems. The AquaBeam System utilizes a heat-free approach and along with the combination of image guidance and robotics has the potential to standardize BPH surgery, reduce the level of complexity required to deliver safe and effective therapy and ultimately improve the quality of life for men suffering from BPH.   This trial has been designed to evaluate these measures,”  co-principal investigator Dr. Peter Gilling of New Zealand’s Tauranga Hospital said in prepared remarks.

The company won investigational device exemption from the FDA for the prospective randomized trial, which is slated to enroll 200 male patients between 45 and 80 years old at 20 global sites, with 12 located in the U.S.

“The early clinical experience with Aquablation has demonstrated much promise and has evolved into a treatment scalable to hospitals worldwide. The initiation of the Water study is an important step to achieve our goal of providing men suffering from BPH a minimally invasive solution that offers both a sustainable and significant improvement to quality of life and a reduced risk of sexual side effects,” CEO Nikolai Aljuri said in a prepared statement.

The AquaBeam device uses a high-pressure water jet to excise tissue from the prostate. The jet’s pressure is then reduced so that is can be used to carry a laser light beam to cauterize the incision. The aim is to reduce the heat damage to adjacent tissue common in more standard interventions. The system uses image-based ultrasound to help surgeons map, plan and execute the procedure.

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