AQUABEAM India Study for the Treatment of Benign Prostatic Hyperplasia

Not Applicable

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Device: AquaBeam System

• 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

Study Timeline

• Study First Submitted: 2014-12-11
• Study Start: 2014-12-14
• Primary Completion: 2016-06-30
• Study Completion: 2017-04-27
• Study First Submitted QC: 2017-05-24
• Study First Posted: 2017-05-25
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-13
• Last Update Posted: 2017-11-17

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

Arm && Interventions

Group	Intervention	Description
Single Arm	AquaBeam System	AquaBeam System for resection and removal of prostatic tissue in males suffering from BPH

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

Trial Locations

Locations (1)

Muljibhai Patel Urological Hospital; 🇮🇳 Nadiad, Gujarat, India