Safety and Efficacy Study for the Treatment of BPH (Enlarged Prostate)

NACompletedINTERVENTIONAL
Enrollment

197

Participants

Timeline

Start Date

July 31, 2013

Primary Completion Date

March 31, 2015

Study Completion Date

October 17, 2016

Conditions
Benign Prostatic HyperplasiaLower Urinary Tract Symptom
Interventions
DEVICE

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."

PROCEDURE

Rigid Cystoscopy

Endoscopy of the urinary bladder via the urethra.

Trial Locations (15)

10016

Manhattan Medical Research, New York

21204

Chesapeake Urology, Towson

29572

Carolina Urologic Research Center, Myrtle Beach

33180

South Florida Medical Research, Aventura

44195

Cleveland Clinic, Cleveland

45212

The Urology Group, Cincinnati

55125

Metro Urology, Woodbury

55905

Mayo Clinic, Rochester

62794

Southern Illinois University, Springfield

75010

Texas Urology, Carrollton

75390

UT Southwestern, Dallas

78229

Urology of San Antonio, San Antonio

80113

Urology Associates of Denver, Denver

84124

Jean Brown Research, Salt Lake City

85704

Arizona Institute of Urology, Tucson

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY

NCT01912339 - Safety and Efficacy Study for the Treatment of BPH (Enlarged Prostate) | Biotech Hunter | Biotech Hunter