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

October 18, 2019 updated by: PROCEPT BioRobotics
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

178

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3050
        • Royal Melbourne Hospital
  • Germany
      • Hamburg, Germany, 21075
        • Asklepios Klinikum Harburg
  • Lebanon
      • Beirut, Lebanon
        • American University of Beirut Medical Center
  • New Zealand
      • Tauranga, New Zealand, 3112
        • Tauranga Urology Research
  • United Kingdom
    • Surrey
      • Frimley, Surrey, United Kingdom, GU16 7UJ
        • Frimley Park Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Participants with lower urinary tract symptoms, including those with urinary retention, who meet all other enrollment criteria.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IPSS score change
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PROCEPT BioRobotics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 5, 2017

Primary Completion (ACTUAL)

May 24, 2019

Study Completion (ANTICIPATED)

February 29, 2020

Study Registration Dates

First Submitted

November 23, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (ESTIMATE)

November 28, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2019

Last Update Submitted That Met QC Criteria

October 18, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TP0118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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