Optimized Water Vapor Thermal Therapy for Benign Prostatic Hyperplasia

NANot yet recruitingINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

September 30, 2024

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2027

Conditions
Benign Prostatic Hyperplasia
Interventions
DEVICE

Rezum

The Rezum System is designed to treat patients with urinary symptoms associated with BPH. The Rezum System utilizes radiofrequency current to generate thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate in controlled 9-second doses. The vapor 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.

All Listed Sponsors
lead

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER