PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs
NCT06051942 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125
Last updated 2026-01-28
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
- 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.
Sponsors & Collaborators
-
PROCEPT BioRobotics
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Max Age
- 80 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-22
- Primary Completion
- 2026-07-31
- Completion
- 2027-03-31
- FDA Device
- Yes
Countries
- United States
- Hong Kong
- Lebanon
- New Zealand
Study Locations
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