Comparing UroLift Experience Against Rezūm (CLEAR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Device: UroLift; Device: Rezum

Detailed Description

Patients will be randomized to either the UroLift or Rezum arm. Post-procedure, subjects who receive a catheter between post-procedure and prior to discharge, will return to office to complete a voiding assessment.

All subjects will be expected to complete questionnaires and assessments, as part of SOC (varies by institution), at day 3, day 7, 2 weeks, 1 month, 3 months and 12 months post-procedure.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adriann Taylor; Phone Number: 919-812-9982; Email: adriann.taylor@teleflex.com

Study Locations

• United Kingdom
  • Camberley
    • Frimley, Camberley, United Kingdom, 6U167UJ UK
      • Active, not recruiting
      • Frimley Park Hospital
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR4 7UY
      • Recruiting
      • Norfolk and Norwich University Hospital
      • Contact: Mark Rochester, MD
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Tower Urology
      • Contact: Arnold Cinman, MD
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Terminated
      • Comprehensive Urology
  • New York
    • Garden City, New York, United States, 11530
      • Active, not recruiting
      • NYU Winthrop Urology
    • New York, New York, United States, 10065
      • Active, not recruiting
      • Weil Cornell Medical College, Cornell University
  • Texas
    • Austin, Texas, United States, 78759
      • Recruiting
      • Urology Austin
      • Contact: Brian Mazzarella, MD
    • Dallas, Texas, United States, 75048
      • Recruiting
      • UT Southwestern Medical Center
      • Contact: Claus Roehrborn, MD
    • San Antonio, Texas, United States, 78229
      • Active, not recruiting
      • Urology San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male gender
2. Age ≥ 50 years
3. Diagnosis of symptomatic BPH
4. Prostate volume 30cm3 ≤ 80cm3
5. Willing to sign study informed consent form

Exclusion Criteria:

1. Current urinary tract infection
2. Current catheter dependent urinary retention or PVR >= 500 mL
3. Urethra conditions that may prevent insertion of delivery system into bladder
4. Previous BPH surgical procedure
5. Urinary incontinence presumed due to incompetent sphincter
6. Current gross hematuria
7. Patients with a urinary sphincter implant
8. Patients who have a penile prosthesis
9. Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UroLift; Patient randomized to the UroLift arm will receive the FDA-approved UroLift procedure.	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.
Experimental: Rezūm; Patient randomized to the Rezūm arm will receive the FDA-approved Rezūm procedure.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Catheter Independent	Number of subjects who are catheter independent and remain catheter independent through 1-week	Through 1-week

Collaborators and Investigators

• Sponsor: NeoTract, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: April 2, 2020
• First Submitted That Met QC Criteria: April 6, 2020
• First Posted (Actual): April 8, 2020

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: CP00013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes