The goal of this clinical trial is to evaluate the safety of the AQUABEAM Robotic System in treating patients with localized prostate cancer. Participants will go through baseline and follow up assessments up to 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
22
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.
University of Southern California, Institute of Urology
Los Angeles, California, United States
NorthShore University HealthSystem
Glenview, Illinois, United States
NYU Grossman School of Medicine
New York, New York, United States
Proportion of participants who experience a serious device-related adverse event within 12 months following the study treatment.
The primary endpoint is the proportion (percentage) of participants who experience a serious device-related adverse event within 12 months following the study treatment.
Time frame: 12 months post-treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.