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Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II (WATERII)

This study is currently recruiting participants.
Verified November 2017 by PROCEPT BioRobotics
Sponsor:
ClinicalTrials.gov Identifier:
NCT03123250
First Posted: April 21, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
PROCEPT BioRobotics
  Purpose
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).The primary endpoints for safety and effectiveness will be measured at 3 months post-treatment. All treated subjects will be followed out to 12 months to collect long-term clinical data.

Condition Intervention
Benign Prostatic Hyperplasia (BPH) Device: Aquablation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II

Resource links provided by NLM:


Further study details as provided by PROCEPT BioRobotics:

Primary Outcome Measures:
  • Incidence of Clavien-Dindo Adverse Events [ Time Frame: 3 months post-treatment ]
    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.

  • International Prostate Symptom Score score change [ Time Frame: 3 months post-treatment ]
    Change in total IPSS score at 3 months as compared to baseline


Estimated Enrollment: 100
Actual Study Start Date: September 6, 2017
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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:

  • Any severe illness that would prevent complete study participation or confound study results.
  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): NCT03123250


Contacts
Contact: Angela Lee 650.232.7215 a.lee@procept-biorobotics.com
Contact: Barry Templin 650.232.7226 b.templin@procept-biorobotics.com

Locations
United States, Arizona
Mayo Clinic Arizona Not yet recruiting
Phoenix, Arizona, United States, 85054
Contact: Vy Nguyen         
Principal Investigator: Mitchell Humphreys, MD         
United States, California
University of Southern California, Institute of Urology Not yet recruiting
Los Angeles, California, United States, 90089
Contact: Ileana Aldana         
Principal Investigator: Mihir Desai, MD         
San Diego Clinical Trials Not yet recruiting
San Diego, California, United States, 92120
Contact: Jennifer Hilton         
Principal Investigator: Mohamed Bidair, MD         
United States, Indiana
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Lori Rawlings, RN, BSN         
Principal Investigator: James Lingeman, MD, FACS         
United States, Nebraska
Adult & Pediatrics Urology Recruiting
Omaha, Nebraska, United States, 68114
Contact: Amy Nelson, MA, BS, CCRC         
Principal Investigator: Andrew Trainer, MD         
United States, New York
Albany Medical College Not yet recruiting
Albany, New York, United States, 12208
Contact: Laura Davey, CCRC         
Contact: Brenda Romeo         
Principal Investigator: Ronald Kaufman, MD         
Icahn School of Medicine at Mount Sinai Not yet recruiting
New York, New York, United States, 10029
Contact: Macy Kate, RN         
Contact: Cynthia Knauer, RN         
Principal Investigator: Steven Kaplan, MD         
United States, North Carolina
Wake Forest School of Medicine Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Mary-Clare Day, RN, BSN         
Principal Investigator: Gopal Badlani, MD         
United States, Texas
UT Southwestern Medical Center Not yet recruiting
Dallas, Texas, United States, 75390-9110
Contact: Allison Beaver         
Principal Investigator: Claus Roehrborn, MD         
United States, Vermont
University of Vermont Not yet recruiting
Burlington, Vermont, United States, 05054
Contact: Sean Linehan         
Principal Investigator: Mark Plante, MD, FRCS(C)         
United States, Virginia
Virginia Urology Recruiting
Richmond, Virginia, United States, 23235
Contact: Nada Woods         
Principal Investigator: Eugene Kramolowsky, MD         
Urology of Virginia Not yet recruiting
Virginia Beach, Virginia, United States, 23462
Contact: Laurie Jackson         
Principal Investigator: Gregg Eure, MD, F.A.C.S         
Canada, British Columbia
University of British Columbia Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Caroline Okulicz         
Principal Investigator: Larry Goldenberg, MD         
Principal Investigator: Ryan Paterson, MD         
Canada, Ontario
University of Toronto-University Health Network Not yet recruiting
Toronto, Ontario, Canada, M5G 1Z6
Contact: Shaun Shepherd         
Principal Investigator: Dean Elterman, MD         
Canada, Quebec
Université de Montréal Not yet recruiting
Montréal, Quebec, Canada, H2X 0A9
Contact: Helene Leonard, M.S.c         
Principal Investigator: Kevin Zorn, MDCM, FACS         
Sponsors and Collaborators
PROCEPT BioRobotics
  More Information

Responsible Party: PROCEPT BioRobotics
ClinicalTrials.gov Identifier: NCT03123250     History of Changes
Other Study ID Numbers: TP0124
First Submitted: April 11, 2017
First Posted: April 21, 2017
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by PROCEPT BioRobotics:
Lower Urinary Tract Symptoms (LUTS)
AQUABEAM
Aquablation
Benign Prostatic Hyperplasia (BPH)

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