AQUABEAM India Study for the Treatment of Benign Prostatic Hyperplasia
Not Applicable
Completed
- Conditions
- Benign Prostatic Hyperplasia
- Registration Number
- NCT03167294
- Lead Sponsor
- PROCEPT BioRobotics
- Brief Summary
Single-arm prospective, interventional clinical trial. Results will be compared to a historical control in the treatment of benign prostatic hyperplasia
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 47
Inclusion Criteria
- Male
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Primary Device Performance Endpoint 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. 6 months The primary safety endpoint of the study is the perioperative complication rate
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Muljibhai Patel Urological Hospital
🇮🇳Nadiad, Gujarat, India
Muljibhai Patel Urological Hospital🇮🇳Nadiad, Gujarat, India