Minimally Invasive Prostatic Vapor Ablation for the Treatment of BPH in Large Prostates (Rezūm XL)

NATerminatedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

June 19, 2018

Primary Completion Date

June 25, 2020

Study Completion Date

August 11, 2020

Conditions
BPH With Urinary ObstructionBPHBPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
Interventions
DEVICE

Prostatic Vapor Ablation

"Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.~Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response."

Trial Locations (10)

2076

Sydney Adventist Hospital/University of Sydney, Wahroonga

21204

Chesapeake Urology Associates, LLC, Towson

33710

Pinellas Urology, LLC, St. Petersburg

47130

First Urology, PSC, Jeffersonville

66160

University of Kansas Medical Center, Kansas City

68114

Adult & Pediatric Urology, P.C., Omaha

77030

Houston Metro Urology, Houston

78229

Urology San Antonio, San Antonio

85258

Arizona Urology Specialists, Scottsdale

08244

Jersey Urology Group, Somers Point

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY

NCT03605745 - Minimally Invasive Prostatic Vapor Ablation for the Treatment of BPH in Large Prostates (Rezūm XL) | Biotech Hunter | Biotech Hunter