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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
101
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.
Mayo Clinic Arizona
Phoenix, Arizona, United States
Tibor Rubin VA Medical Center
Long Beach, California, United States
Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment
The percentage of subjects with adverse events rated as probably or definitely related to the study procedure classified as Clavien-Dindo Grade 2 or higher or any Grade 1 event resulting in persistent disability (e.g. ejaculatory disorder or erectile dysfunction) evidenced through 3 months post treatment.
Time frame: 3 months post-treatment
Change in Total International Prostate Symptom Score (IPSS) Score at 3 Months as Compared to Baseline
The change in total IPSS score at 3 months as compared to baseline. The objective of the International Prostate Symptom Score (IPSS) is to capture the severity of urinary symptoms related to benign prostatic hyperplasia IPSS ranges from 0 to 35. A higher score indicates a worse outcome.
Time frame: 3 months post-treatment
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University of Southern California, Institute of Urology
Los Angeles, California, United States
San Diego Clinical Trials
San Diego, California, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Adult & Pediatrics Urology
Omaha, Nebraska, United States
Albany Medical College
Albany, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States
...and 6 more locations