MedTrace Logo

Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER)

NCT02505919 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2023-07-03

Study results available
· View outcomes & findings →

Summary

A prospective multicenter randomized blinded study comparing Aquablation of the prostate with the AQUABEAM System and TURP for the treatment of Lower Urinary Tract Symptoms (LUTS). The primary endpoints for safety and effectiveness were measured at 3 and 6 months, respectively, and subjects were followed out to 5 years to collect long-term clinical data.

Conditions

  • Benign Prostatic Hyperplasia (BPH)

Interventions

DEVICE

AQUABEAM System

The AQUABEAM system, a personalized image-guided tissue removal system, utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue.

PROCEDURE

Transurethral Resection of the Prostate (TURP)

Transurethral resection of the prostate (TURP) is a type of prostate surgery done to relieve moderate to severe urinary symptoms caused by an enlarged prostate, a condition known as benign prostatic hyperplasia (BPH)

Sponsors & Collaborators

  • PROCEPT BioRobotics

    lead INDUSTRY

Principal Investigators

  • Peter Gilling, M.D. · Urology BOP

  • Claus Roehrborn, M.D. · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-30
Primary Completion
2017-07-14
Completion
2021-12-16

Countries

  • United States
  • Australia
  • New Zealand
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02505919 on ClinicalTrials.gov