50
Participants
Start Date
March 31, 2012
Primary Completion Date
February 28, 2013
Study Completion Date
December 31, 2018
Rezum System
"The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate wet thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure."
University Hospital, Brno
Clinica Canela, La Romana
Urologcentrum, Stockholm
Lead Sponsor
Boston Scientific Corporation
INDUSTRY