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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02505919
First Posted: July 22, 2015
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
PROCEPT BioRobotics
  Purpose
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
Benign Prostatic Hyperplasia (BPH) Device: AQUABEAM System Procedure: Transurethral Resection of the Prostate (TURP)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
All study subjects are blinded to the assigned treatment until study exit. One of the investigational site teams is blinded to the randomization assignment as well.
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:
  • Safety: Adverse Events Comparisons using Clavien-Dindo Grading System [ Time Frame: Three months post-treatment ]
    The primary safety endpoint is the proportion 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. Note that the Clavien-Dindo classification scheme is for grading postoperative complications not events that reflect lack of effective treatment.

  • Efficacy: Comparisons of IPSS [ Time Frame: Six months post-treatment ]
    The primary effectiveness endpoint is the IPSS change score from baseline to 6 months.


Enrollment: 203
Actual Study Start Date: November 21, 2015
Estimated Study Completion Date: February 2020
Primary Completion Date: July 14, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
AQUABEAM System
Device: AQUABEAM System
To utilizes proprietary heat-free high-pressure 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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Prostate size

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02505919


Locations
United States, Alabama
Urology Centers of Alabama
Birmingham, Alabama, United States, 35209
United States, California
University of Southern California, Institute of Urology
Los Angeles, California, United States, 90089
San Diego Clinical Trials
San Diego, California, United States, 92120
United States, Colorado
Urology Associates, P.C.
Englewood, Colorado, United States, 80113
United States, Nebraska
Adult & Pediatric Urology P.C.
Omaha, Nebraska, United States, 68114
United States, New York
Albany Medical College
Albany, New York, United States, 12208
Weill Cornell Medical College
New York, New York, United States, 10065
United States, North Carolina
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390-9110
Houston Metro Urology
Houston, Texas, United States, 77030
United States, Vermont
University of Vermont College of Medicine
Burlington, Vermont, United States, 05401
United States, Virginia
Virginia Urology
Richmond, Virginia, United States, 23235
Australia, Victoria
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
New Zealand
Urology BOP
Tauranga, New Zealand, 3112
United Kingdom
Frimley Park Hospital
Frimley, Surrey, United Kingdom, GU16 7UJ
Princess of Wales Hospital
Bridgend, Wales, United Kingdom, CF31 1RQ
Addenbrooke's Treatment Center
Cambridge, United Kingdom, CB2 0QQ
Sponsors and Collaborators
PROCEPT BioRobotics
Investigators
Principal Investigator: Peter Gilling, M.D. Urology BOP
Principal Investigator: Claus Roehrborn, M.D. UT Southwestern Medical Center
  More Information

Responsible Party: PROCEPT BioRobotics
ClinicalTrials.gov Identifier: NCT02505919     History of Changes
Other Study ID Numbers: TP0038
First Submitted: July 21, 2015
First Posted: July 22, 2015
Last Update Posted: November 17, 2017
Last Verified: November 2017

Keywords provided by PROCEPT BioRobotics:
Lower Urinary Tract Symptoms (LUTS)

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male