Status:
COMPLETED
Randomized Controlled Trial Comparing Two Different Morcellators for HoLEP Procedures
Lead Sponsor:
Indiana Kidney Stone Institute
Collaborating Sponsors:
Richard Wolf Medical Instruments Corporation (RWMIC)
Conditions:
Benign Prostatic Hypertrophy Requiring Surgical Intervention
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
To compare efficiency, in terms of tissue morcellation and removal time, of two commercially available FDA-approved morcellators: the VersaCut and the Piranha in subjects undergoing HoLEP procedure fo...
Detailed Description
Holmium laser enucleation of the prostate (HoLEP) with mechanical morcellation is a surgical technique used for treatment of bladder outlet obstruction (BOO) secondary to benign prostatic hyperplasia ...
Eligibility Criteria
Inclusion
- Patients scheduled to undergo HoLEP for bladder outlet obstruction due to the prostate.
- Able to give informed consent.
- Age 18 years or older
Exclusion
- • Inability to give informed consent.
- Age less than 18 years
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT02195622
Start Date
September 1 2013
End Date
February 1 2016
Last Update
March 11 2019
Active Locations (1)
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1
IU Health Physicians Urology
Indianapolis, Indiana, United States, 46202