NCT03123250

Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: PROCEPT BioRobotics · Industry
• Sex: Male
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Benign Prostatic Hyperplasia (BPH)

Interventions

Type	Name	Description
DEVICE	Aquablation	The procedure is performed with the AquaBeam System. It is designed to utilize a high-velocity sterile saline waterjet as the cutting medium, which is projected through a nozzle positioned within the prostatic urethra. The Aquablation procedure integrates real-time ultrasound imaging with a robotically executed surgeon guided high-velocity waterjet to resect prostate tissue.

Timeline

• Start date: 2017-08-14
• Primary completion: 2018-03-27
• Completion: 2022-12-20
• First posted: 2017-04-21
• Last updated: 2023-06-28
• Results posted: 2023-06-28

Locations

16 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study