Minimally Invasive Prostatic Vapor Ablation for the Treatment of BPH in Large Prostates (Rezūm XL) (Rezūm XL)
|ClinicalTrials.gov Identifier: NCT03605745|
Recruitment Status : Terminated (Sponsor decided to terminate the study due to business reasons)
First Posted : July 30, 2018
Last Update Posted : September 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|BPH With Urinary Obstruction BPH BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms||Device: Prostatic Vapor Ablation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This study is a prospective, non-randomized clinical trial of subjects with benign prostatic hypertrophy (BPH).|
|Masking:||None (Open Label)|
|Official Title:||Minimally Invasive Prostatic Vapor Ablation - Multicenter, Single Arm Study for the Treatment of BPH in Large Prostates (Rezūm XL)|
|Actual Study Start Date :||June 19, 2018|
|Actual Primary Completion Date :||June 25, 2020|
|Actual Study Completion Date :||August 11, 2020|
Prostatic Vapor Ablation with Rezum
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.
- IPSS Improvement [ Time Frame: 6 Months ]The proportion of the intent-to-treat (ITT) analysis population that responds to therapy must be statistically significantly greater than 50%. A responder is defined as a subject who has an IPSS improvement > 30% post-treatment compared to baseline.
- Post Procedure Device Related Serious Complications [ Time Frame: 6 Months ]Demonstration that the composite rate of post procedure device related serious complications in treated subjects is statistically significantly less than 12% at 6 months.
- Device-related retention catheterization rate [ Time Frame: 6 Month ]This safety endpoint will be to characterize the rate of post procedure device-related serious retention catheterizations at 6 months.
- Absolute IPSS improvement at 6 Months [ Time Frame: 6 Months ]
- Percent IPSS Responders at 1 year [ Time Frame: 1 Year ]The endpoint is defined as the same as the primary objective, but will be evaluated at 1 year of follow-up.
- Percent IPSS Responders at 2 years [ Time Frame: 2 Years ]The endpoint is defined as the same as the primary objective, but will be evaluated at 2 years of follow-up.
- Percent IPSS Responders at 3 years [ Time Frame: 3 Years ]The endpoint is defined as the same as the primary objective, but will be evaluated at 3 years of follow-up.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03605745
|United States, Arizona|
|Arizona Urology Specialists|
|Scottsdale, Arizona, United States, 85258|
|United States, Florida|
|Pinellas Urology, LLC|
|Saint Petersburg, Florida, United States, 33710|
|United States, Indiana|
|First Urology, PSC|
|Jeffersonville, Indiana, United States, 47130|
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|United States, Maryland|
|Chesapeake Urology Associates, LLC|
|Towson, Maryland, United States, 21204|
|United States, Nebraska|
|Adult & Pediatric Urology, P.C.|
|Omaha, Nebraska, United States, 68114|
|United States, New Jersey|
|Jersey Urology Group|
|Somers Point, New Jersey, United States, 08244|
|United States, Texas|
|Houston Metro Urology|
|Houston, Texas, United States, 77030|
|Urology San Antonio|
|San Antonio, Texas, United States, 78229|
|Australia, New South Wales|
|Sydney Adventist Hospital/University of Sydney|
|Wahroonga, New South Wales, Australia, 2076|
|Principal Investigator:||Henry Woo, MD||Sydney Adventist Hospital|