197
Participants
Start Date
July 31, 2013
Primary Completion Date
March 31, 2015
Study Completion Date
October 17, 2016
Rezum System
"The Rezūm System uses sterile water vapor (steam) to treat BPH by delivering targeted, controlled doses of stored thermal energy directly to the transition zone of the prostate gland.~A narrow sheath, similar in shape and size to a cystoscope, is inserted transurethrally and positioned within the prostatic urethra between the bladder neck and the verumontanum.~A thin needle is deployed through the urethra into the transition zone, and a very short (8-10 second) treatment of water vapor is delivered directly into the hyperplastic tissue and immediately disperses through the tissue interstices.~Upon contact with the tissue, the vapor condenses, or phase shifts, into its liquid state, releasing the stored thermal energy contained within the vapor. This thermal energy is released directly against the walls of the tissue cells within the treatment zone, gently and immediately denaturing the cell membranes, thereby causing instantaneous cell death."
Rigid Cystoscopy
Endoscopy of the urinary bladder via the urethra.
Manhattan Medical Research, New York
Chesapeake Urology, Towson
Carolina Urologic Research Center, Myrtle Beach
South Florida Medical Research, Aventura
Cleveland Clinic, Cleveland
The Urology Group, Cincinnati
Metro Urology, Woodbury
Mayo Clinic, Rochester
Southern Illinois University, Springfield
Texas Urology, Carrollton
UT Southwestern, Dallas
Urology of San Antonio, San Antonio
Urology Associates of Denver, Denver
Jean Brown Research, Salt Lake City
Arizona Institute of Urology, Tucson
Lead Sponsor
Boston Scientific Corporation
INDUSTRY