AQUABEAM India Study for the Treatment of Benign Prostatic Hyperplasia (ABS)

November 13, 2017 updated by: PROCEPT BioRobotics

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Gujarat
      • Nadiad, Gujarat, India, 387001
        • Muljibhai Patel Urological Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single Arm
AquaBeam System for resection and removal of prostatic tissue in males suffering from BPH
Device: AquaBeam System
Aquablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Device Performance Endpoint
Time Frame: 6 months
The primary device performance endpoint is completion of the intended surgical procedure.
6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PROCEPT BioRobotics

Investigators

  • Principal Investigator: Ravindra Sabnis, Chairman, department of Urology Muljibhai Patel Urological Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2014

Primary Completion (Actual)

June 30, 2016

Study Completion (Actual)

April 27, 2017

Study Registration Dates

First Submitted

December 11, 2014

First Submitted That Met QC Criteria

May 24, 2017

First Posted (Actual)

May 25, 2017

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 13, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP0032

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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