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

• ClinicalTrials.gov Identifier: NCT02974751
• Recruitment Status: Unknown
• First Posted: November 28, 2016
• Last Update Posted: October 22, 2019
• Sponsor: PROCEPT BioRobotics
• 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
• 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

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

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