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Global Post-Market Registry Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (OPEN WATER)

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. Identifier: NCT02974751
Recruitment Status : Unknown
Verified October 2019 by PROCEPT BioRobotics.
Recruitment status was:  Active, not recruiting
First Posted : November 28, 2016
Last Update Posted : October 22, 2019
Information provided by (Responsible Party):
PROCEPT BioRobotics

Brief Summary:
The purpose of this study is to evaluate the efficacy of the AQUABEAM System for the treatment of Lower Urinary Tract Symptoms (LUTS) resulting from Benign Prostatic Hyperplasia (BPH).

Condition or disease Intervention/treatment
BPH Procedure: Aquablation

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Study Type : Observational [Patient Registry]
Actual Enrollment : 178 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Global Post-Market Registry Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue
Actual Study Start Date : September 5, 2017
Actual Primary Completion Date : May 24, 2019
Estimated Study Completion Date : February 29, 2020

Intervention Details:
  • Procedure: Aquablation
    Aquablation is a minimally invasive transurethral surgical procedure using the AQUABEAM system, a personalized image-guided waterject resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue.

Primary Outcome Measures :
  1. IPSS score change [ Time Frame: 3 months ]

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.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with lower urinary tract symptoms, including those with urinary retention, who meet all other enrollment criteria.

Inclusion Criteria:

  • Male.
  • Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction or in urinary retention.
  • Prostate size ≥ 20 mL and ≤ 150 mL as measure by TRUS.
  • Patient is mentally capable and willing to sign a study-specific informed consent form.

Exclusion Criteria:

  • 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.
  • History of gross haematuria.
  • Participants using systemic immune-suppressants including corticosteroids (except inhalants), known coagulopathy, or platelet disorder (except aspirin below 100mg/d).
  • Contraindication to both general and spinal anesthesia.
  • Any severe illness that would prevent complete study participation or confound study results.
  • 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 identifier (NCT number): NCT02974751

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Australia, Victoria
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Asklepios Klinikum Harburg
Hamburg, Germany, 21075
American University of Beirut Medical Center
Beirut, Lebanon
New Zealand
Tauranga Urology Research
Tauranga, New Zealand, 3112
United Kingdom
Frimley Park Hospital
Frimley, Surrey, United Kingdom, GU16 7UJ
Sponsors and Collaborators
PROCEPT BioRobotics
Additional Information:

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Responsible Party: PROCEPT BioRobotics Identifier: NCT02974751    
Other Study ID Numbers: TP0118
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PROCEPT BioRobotics: