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ACTIVE NOT RECRUITING
NCT04338776
NA

Comparing UroLift Experience Against Rezūm

Sponsor: NeoTract, Inc.

View on ClinicalTrials.gov

Summary

C.L.E.A.R. Study is poised to compare the patient experience post procedure, including catheterization needs as well as retreatment and BPH medication rates following treatment with either the UroLift® System or Rezūm™ System through 12 months.

Official title: C.L.E.A.R. - Comparing UroLift Experience Against Rezūm

Key Details

Gender

MALE

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2021-01-22

Completion Date

2025-12

Last Updated

2025-10-14

Healthy Volunteers

Yes

Interventions

DEVICE

UroLift

The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra.

DEVICE

Rezum

The Rezūm™ System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. The Rezūm System is manufactured by Boston Scientific and consists of a radiofrequency (RF) generator and a single-use transurethral delivery device. 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,reducing the volume tissue adjacent to the urethra.

Locations (10)

Tower Urology

Los Angeles, California, United States

Comprehensive Urology

Royal Oak, Michigan, United States

NYU Winthrop Urology

Garden City, New York, United States

Weil Cornell Medical College, Cornell University

New York, New York, United States

Urology Austin

Austin, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Urology San Antonio

San Antonio, Texas, United States

Frimley Park Hospital

Frimley, Camberley, United Kingdom

NORFOLK and Norwich University Hospital

Norwich, Norfolk, United Kingdom

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom