Rezum FIM Optimization Study

NACompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

March 19, 2012

Primary Completion Date

May 19, 2017

Study Completion Date

May 19, 2017

Conditions
Benign Prostatic HyperplasiaAdenoma, ProstaticProstatic AdenomaProstatic Hyperplasia, BenignProstatic HypertrophyProstatic Hypertrophy, BenignRezum
Interventions
DEVICE

Rezum System

"The Rezūm System is designed to treat 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."

Trial Locations (1)

Unknown

Clinica Canela, La Romana

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY

NCT02940392 - Rezum FIM Optimization Study | Biotech Hunter | Biotech Hunter