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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.
 
ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
PROCEPT BioRobotics

Tracking Information
First Submitted Date November 23, 2016
First Posted Date November 28, 2016
Last Update Posted Date October 22, 2019
Actual Study Start Date September 5, 2017
Actual Primary Completion Date May 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 23, 2016)
IPSS score change [ Time Frame: 3 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Global Post-Market Registry Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue
Official Title Global Post-Market Registry Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue
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).
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Participants with lower urinary tract symptoms, including those with urinary retention, who meet all other enrollment criteria.
Condition BPH
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: October 18, 2019)
178
Original Estimated Enrollment
 (submitted: November 23, 2016)
200
Estimated Study Completion Date February 29, 2020
Actual Primary Completion Date May 24, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Male
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Germany,   Lebanon,   New Zealand,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02974751
Other Study ID Numbers TP0118
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party PROCEPT BioRobotics
Study Sponsor PROCEPT BioRobotics
Collaborators Not Provided
Investigators Not Provided
PRS Account PROCEPT BioRobotics
Verification Date October 2019