CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 184 enrolled
Drug / intervention
AQUABEAM System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02505919
NCT02505919N/ACompleted
CompareCT.gov

A Prospective Multicenter Randomized Blinded Study Comparing Aquablation of the Prostate With the AQUABEAM System and TURP for the Treatment of LUTS

PROCEPT BioRobotics·interventional·Posted Jul 22, 2015·Updated Jul 3, 2023

In Brief

A clinical study evaluating AQUABEAM System and Transurethral Resection of the Prostate (TURP) for Benign Prostatic Hyperplasia (BPH). Completed, enrolled 184 participants across 17 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBenign Prostatic Hyperplasia (BPH)
CountriesAustralia, New Zealand, United Kingdom, United States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 22, 2015
Enrollment StartOct 30, 2015
Primary CompletionJul 14, 2017
Study CompletionDec 16, 2021
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.9 years ago

Interventions

AQUABEAM Systemdevice

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

Transurethral Resection of the Prostate (TURP)procedure

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)