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

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.
ClinicalTrials.gov Identifier: NCT03123250
Recruitment Status : Active, not recruiting
First Posted : April 21, 2017
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
PROCEPT BioRobotics

Brief Summary:
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 or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia (BPH) Device: Aquablation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II
Actual Study Start Date : September 6, 2017
Actual Primary Completion Date : March 27, 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

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



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Male age 45-80 years.
  • Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction.
  • Subject has an IPSS score greater than or equal to 12.
  • Maximum urinary flow rate (Qmax) less than 15mL/s.
  • Serum creatinine < 2 mg/dL within 30 days of surgery.
  • History of inadequate or failed response, contraindication, or refusal to medical therapy.
  • Prostate size ≥ 80 mL and ≤ 150 mL as measured by TRUS.
  • Patient is mentally capable and willing to sign a study-specific informed consent form.

Exclusion Criteria:

  • BMI ≥ 42.
  • Patients unable to stop anticoagulants, antiplatelet agents, or non-steroidal anti-inflammatory agents (NSAIDs, including aspirin greater or equal to 100mg) prior to treatment per standard of care.
  • Participants using systemic immune-suppressants including corticosteroids (except inhalants); unable to withhold non-steroidal anti-inflammatory agents (NSAIDs, including aspirin) prior to treatment per standard or care except for low dose aspirin (e.g. less than or equal to 100mg).
  • Contraindication to both general and spinal anesthesia.
  • Any severe illness that would prevent complete study participation or confound study results.
  • History of prostate cancer or current/suspected bladder cancer. Prostate cancer should be ruled out before participation to the satisfaction of the investigator if PSA is above acceptable thresholds.
  • History of actively treated bladder cancer within the past two (2) years.
  • Clinically significant bladder calculus or bladder diverticulum (e.g., pouch size >20% of full bladder size).
  • Active infection, including urinary tract infection or prostatitis.
  • Urinary catheter use daily for 90 or more days consecutively.
  • Previous urinary tract surgery such as e.g. urinary diversion, artificial urinary sphincter or penile prosthesis.
  • Ever been diagnosed with a clinically significant urethral stricture or meatal stenosis, or bladder neck contracture.
  • Known damage to external urinary sphincter.
  • Has had an open heart surgery, or cardiac arrest < 180 days prior to the date of informed consent.
  • Participants using anticholinergics specifically for bladder problems. Use of medications with anticholinergic properties is allowable provided the patient does not have documented adverse urinary side effects from these medications.
  • Subject is unwilling to accept a transfusion should one be required.

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


Locations
United States, Arizona
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
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, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Nebraska
Adult & Pediatrics Urology
Omaha, Nebraska, United States, 68114
United States, New York
Albany Medical College
Albany, New York, United States, 12208
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
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
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05054
United States, Virginia
Virginia Urology
Richmond, Virginia, United States, 23235
Urology of Virginia
Virginia Beach, Virginia, United States, 23462
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
University of Toronto-University Health Network
Toronto, Ontario, Canada, M5G 1Z6
Canada, Quebec
Université de Montréal
Montréal, Quebec, Canada, H2X 0A9
Sponsors and Collaborators
PROCEPT BioRobotics

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PROCEPT BioRobotics
ClinicalTrials.gov Identifier: NCT03123250     History of Changes
Other Study ID Numbers: TP0124
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
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