127
Participants
Start Date
June 22, 2018
Primary Completion Date
December 10, 2020
Study Completion Date
March 31, 2026
Optilume Drug Coated Balloon (DCB)
The Optilume Drug Coated Balloon (DCB) is a guidewire compatible catheter with a tapered atraumatic tip. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation.
Control Treatment
A control subject may be dilated with either a rod, uncoated balloon or DVIU until the desired result is reached, based on standard of care for the clinical site and treating physician
Columbia University Medical Center/New York-Presbyterian Hospital, New York
Iris Cantor Men's Health Center, New York
Integrated Medical Professionals OBP, North Hills
Western New York Urology Associates, Cheektowaga
Chesapeake Urology, Hanover
Chesapeake Urology Research, Annapolis
Urology of Virginia, Virginia Beach
Carolina Urology Partners, Concord
Advanced Urology Institute, Daytona Beach
University of Iowa, Iowa City
Minnesota Urology, Woodbury
University of Minnesota Department of Urology, Minneapolis
Mayo Clinic, Rochester
Adult & Pediatric Urology, PC, Omaha
Arkansas Urology, Little Rock
UT Southwestern, Dallas
Urology San Antonio, San Antonio
Academic Urology and Urogynecology of Arizona, Phoenix
Oregon Urology Institute, Springfield
University of Washington Harborview Medical Center, Seattle
New Jersey Urology, Voorhees Township
Royal Victoria Hospital, Glen Site, Montreal
Collaborators (2)
Laborie Medical Technologies Inc.
INDUSTRY
NAMSA
OTHER
Urotronic Inc.
INDUSTRY