NCT06051942

PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: PROCEPT BioRobotics · Industry
• Sex: Male
• Age: 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to assess the performance and safety of the AQUABEAM Robotic System for the resection and removal of prostate tissue in patients experiencing lower urinary tract symptoms (LUTS) and are diagnosed with localized prostate cancer. Participants will go through baseline and follow up assessments up to 12 months.

Conditions

• Benign Prostatic Hyperplasia
• Localized Prostate Cancer

Interventions

Type	Name	Description
DEVICE	Robotic Waterjet Treatment	The Aquablation therapy is a minimally invasive, image-guided, heat-free robotic therapy delivered by the AQUABEAM Robotic System. During Aquablation therapy, the AQUABEAM Handpiece is inserted transurethrally into the prostatic urethra. The operating physician then utilizes cystoscopy in conjunction with transrectal ultrasound (TRUS) imaging for real time visualization. The AQUABEAM Robotic System utilizes high-velocity sterile saline waterjet to resect and remove the prostate tissue according to the operating physician's treatment plan.

Timeline

• Start date: 2022-11-22
• Primary completion: 2026-07-01
• Completion: 2027-03-01
• First posted: 2023-09-25
• Last updated: 2026-01-28

Locations

6 sites across 4 countries: United States, Hong Kong, Lebanon, New Zealand

Regulatory

• FDA-regulated device study