Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II (WATERII)

NCT03123250 NA COMPLETED Results posted

Single-arm, interventional pivotal clinical trial collecting patient data from use of the AQUABEAM System, a personalized image-guided waterjet resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue in males suffering from Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH) with prostate volumes between 80 mL and 150 mL. The primary endpoints for safety and effectiveness will be measured at 3 months post-treatment. Treated subjects will be followed out to 60 months to collect long-term clinical data.

Details

Lead sponsor	PROCEPT BioRobotics
Phase	NA
Status	COMPLETED
Enrolment	101
Start date	Mon Aug 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue Dec 20 2022 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Benign Prostatic Hyperplasia (BPH)

Interventions

• Aquablation

Countries

Canada, United States