2-01Please click on one of the maps nearest your geograpical location to learn more about clinical sites in your area.

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 will be measured at 3 and 6 months, respectively, and subjects will be followed out to 3 years to collect long-term clinical data.

Condition Intervention Phase
Benign Prostatic Hyperplasia (BPH) Device: Aquablation
Procedure: Transurethral Resection of the Prostate (TURP)
Phase 3
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Randomized Blinded Study Comparing Aquablation of the Prostate With the AQUABEAM System and TURP for the Treatment of LUTS
Resource links provided by NLM:
Further study details as provided by PROCEPT BioRobotics:

Primary Outcome Measures:

  • Adverse Events Comparison for Safety [ Time Frame: Three months post-treatment ] [ Designated as safety issue: Yes ]
    Three Month comparison between control and treatment arms of AEs
  • IPSS Comparison for Efficacy [ Time Frame: Six months post-treatment ] [ Designated as safety issue: No ]
    Six Month comparison between control and treatment arms of IPSS
Estimated Enrollment: 237
Study Start Date: September 2015
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms  Assigned Interventions
Experimental: Treatment

Aquablation procedure
Device: Aquablation

To utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue using the AQUABEAM system, which is a personalized image-guided tissue removal system.
Active Comparator: Control

Transurethral Resection of the Prostate (TURP)
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)


Ages Eligible for Study: 45 Years to 80 Years
Genders Eligible for Study: Male
Accepts Healthy Volunteers: No

Inclusion Criteria:

– Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction

Exclusion Criteria:

– Prostate size

This information was originally posted on www.clinicaltrials.gov.