ABS: AQUABEAM India Study for the Treatment of Benign Prostatic Hyperplasia
Sponsor
PROCEPT BioRobotics (Industry)
Overall Status
Completed
CT.gov ID
NCT03167294
Collaborator
(none)
47
1
1
28.4
1.7
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
47 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
PROCEPT AQUABEAM Study for the Treatment of Benign Prostatic Hyperplasia (ABS)
Actual Study Start Date
:
Dec 14, 2014
Actual Primary Completion Date
:
Jun 30, 2016
Actual Study Completion Date
:
Apr 27, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Single Arm AquaBeam System for resection and removal of prostatic tissue in males suffering from BPH |
Device: AquaBeam System
Aquablation
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
to 80 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Muljibhai Patel Urological Hospital | Nadiad | Gujarat | India | 387001 |
Sponsors and Collaborators
- PROCEPT BioRobotics
Investigators
- Principal Investigator: Ravindra Sabnis, Chairman, department of Urology Muljibhai Patel Urological Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
PROCEPT BioRobotics
ClinicalTrials.gov Identifier:
NCT03167294
Other Study ID Numbers:
- TP0032
First Posted:
May 25, 2017
Last Update Posted:
Nov 17, 2017
Last Verified:
Nov 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by PROCEPT BioRobotics
Additional relevant MeSH terms: