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NCT03167294 Clinical Trial

AQUABEAM India Study for the Treatment of Benign Prostatic Hyperplasia

Benign Prostatic Hyperplasia Clinical Trial

— ABS  

Official title:
PROCEPT AQUABEAM Study for the Treatment of Benign Prostatic Hyperplasia (ABS)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03167294
Other study ID # TP0032
Secondary ID
Status Completed
Phase N/A
First received December 11, 2014
Last updated November 13, 2017
Start date December 14, 2014
Est. completion date April 27, 2017

Study information
Verified date November 2017
Source PROCEPT BioRobotics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Single-arm prospective, interventional clinical trial. Results will be compared to a historical control in the treatment of benign prostatic hyperplasia

Recruitment information / eligibility
Status Completed
Enrollment 47
Est. completion date April 27, 2017
Est. primary completion date June 30, 2016
Accepts healthy volunteers No
Gender Male
Age group 50 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• AquaBeam System
Aquablation

Locations
Country Name City State
India Muljibhai Patel Urological Hospital Nadiad Gujarat

Sponsors (1)
Lead Sponsor Collaborator
PROCEPT BioRobotics

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary Device Performance Endpoint The primary device performance endpoint is completion of the intended surgical procedure. 6 months
Primary Primary Safety Endpoint of the study is the perioperative complication rate. The primary safety endpoint of the study is the perioperative complication rate 6 months
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