Back to resultsAQUABEAM India Study for the Treatment of Benign Prostatic Hyperplasia (ABS)
Primary Purpose
Benign Prostatic Hyperplasia
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
AquaBeam System
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Aquablation, AQUABEAM, BPH, LUTS
Eligibility Criteria
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
Sites / Locations
- Muljibhai Patel Urological Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single Arm
Arm Description
AquaBeam System for resection and removal of prostatic tissue in males suffering from BPH
Outcomes
Primary Outcome Measures
Primary Device Performance Endpoint
The primary device performance endpoint is completion of the intended surgical procedure.
Primary Safety Endpoint of the study is the perioperative complication rate.
The primary safety endpoint of the study is the perioperative complication rate
Secondary Outcome Measures
Full Information
NCT ID
NCT03167294
First Posted
December 11, 2014
Last Updated
November 13, 2017
Sponsor
PROCEPT BioRobotics
1. Study Identification
Unique Protocol Identification Number
NCT03167294
Brief Title
AQUABEAM India Study for the Treatment of Benign Prostatic Hyperplasia
Acronym
ABS
Official Title
PROCEPT AQUABEAM Study for the Treatment of Benign Prostatic Hyperplasia (ABS)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
December 14, 2014 (Actual)
Primary Completion Date
June 30, 2016 (Actual)
Study Completion Date
April 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PROCEPT BioRobotics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Single-arm prospective, interventional clinical trial. Results will be compared to a historical control in the treatment of benign prostatic hyperplasia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Aquablation, AQUABEAM, BPH, LUTS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Other
Arm Description
AquaBeam System for resection and removal of prostatic tissue in males suffering from BPH
Intervention Type
Device
Intervention Name(s)
AquaBeam System
Intervention Description
Aquablation
Primary Outcome Measure Information:
Title
Primary Device Performance Endpoint
Description
The primary device performance endpoint is completion of the intended surgical procedure.
Time Frame
6 months
Title
Primary Safety Endpoint of the study is the perioperative complication rate.
Description
The primary safety endpoint of the study is the perioperative complication rate
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravindra Sabnis
Organizational Affiliation
Chairman, department of Urology Muljibhai Patel Urological Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Muljibhai Patel Urological Hospital
City
Nadiad
State/Province
Gujarat
ZIP/Postal Code
387001
Country
India
12. IPD Sharing Statement
Learn more about this trial
AQUABEAM India Study for the Treatment of Benign Prostatic Hyperplasia
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