NCT03167294CompletedNot Applicable
PROCEPT AQUABEAM Study for the Treatment of Benign Prostatic Hyperplasia (ABS)
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- PROCEPT BioRobotics
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Primary Device Performance Endpoint
Study Overview
Brief Summary
Single-arm prospective, interventional clinical trial. Results will be compared to a historical control in the treatment of benign prostatic hyperplasia
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •50 - 80 years
- •Moderate to severe BPH
- •Subjects who have failed standard medical therapy
Exclusion Criteria
- •Size and width of prostate
- •Medical condition or co-morbidities where BPH intervention would be contraindicated
Arms & Interventions
Single Arm
Other
AquaBeam System for resection and removal of prostatic tissue in males suffering from BPH
Intervention: AquaBeam System (Device)
Outcomes
Primary Outcomes
Primary Device Performance Endpoint
Time Frame: 6 months
The primary device performance endpoint is completion of the intended surgical procedure.
Primary Safety Endpoint of the study is the perioperative complication rate.
Time Frame: 6 months
The primary safety endpoint of the study is the perioperative complication rate
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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