162
Participants
Start Date
February 5, 2020
Primary Completion Date
August 23, 2022
Study Completion Date
May 31, 2027
Optilume BPH Catheter System
The Optilume™ BPH, Prostatic Dilation DCB Catheter is a dilation catheter used to exert radial force to dilate the prostatic urethra resulting in a commissurotomy. The distal end of the catheter has a semi-compliant inflatable double lobe balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel.
Optilume Sham Device
21 Fr sheathed Optilume™ BPH Prostatic Pre-dilation Catheter (modified to prevent inflation)
Manhattan Medical Research Practice, PLLC, New York
Weill Cornell Medical College, New York
AccuMed Research Associates, Garden City
Chesapeake Urology Research Associates, Hanover
Chesapeake Urology Research Associates, Towson
Associated Urologists of NC, Raleigh
Carolina Urologic Research Center, Myrtle Beach
Advanced Urology Institute, Daytona Beach
Florida Urology Partners, Tampa
Comprehensive Urologic Care, Lake Barrington
Regional Urology, LLC, Shreveport
Arkansas Urology, Little Rock
Clear Lake Specialties, Webster
Urology Austin, PLLC, Austin
North Austin Urology, Austin
Rio Grande Urology, El Paso
Colorado Clinical Research, Golden
Sheldon Freedman MD, Ltd, Las Vegas
New Jersey Urology, Englewood
University Urology Associates, Toronto
University of Montreal Hospital Center (CHUM), Montreal
ClinLogix. LLC
INDUSTRY
Urotronic Inc.
INDUSTRY