NCT04338776

Brief 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.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
2 countries

10 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 8, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

January 22, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 14, 2025

Status Verified

October 1, 2025

Enrollment Period

4.4 years

First QC Date

April 2, 2020

Last Update Submit

October 10, 2025

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • Catheter Independent

    Number of subjects who are catheter independent and remain catheter independent through 1-week

    Through 1-week

Study Arms (2)

UroLift

EXPERIMENTAL

Patient randomized to the UroLift arm will receive the FDA-approved UroLift procedure.

Device: UroLift

Rezūm

EXPERIMENTAL

Patient randomized to the Rezūm arm will receive the FDA-approved Rezūm procedure.

Device: Rezum

Interventions

UroLiftDEVICE

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.

UroLift
RezumDEVICE

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.

Rezūm

Eligibility Criteria

Age50 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsPatients must be male. The study is evaluation the population of men diagnosed with benign prostatic hyperplasia.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male gender
  • Age ≥ 50 years
  • Diagnosis of symptomatic BPH
  • Prostate volume 30cm3 ≤ 80cm3
  • Willing to sign study informed consent form

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Tower Urology

Los Angeles, California, 90048, United States

Location

Comprehensive Urology

Royal Oak, Michigan, 48073, United States

Location

NYU Winthrop Urology

Garden City, New York, 11530, United States

Location

Weil Cornell Medical College, Cornell University

New York, New York, 10065, United States

Location

Urology Austin

Austin, Texas, 78759, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75048, United States

Location

Urology San Antonio

San Antonio, Texas, 78229, United States

Location

Frimley Park Hospital

Frimley, Camberley, 6U167UJ UK, United Kingdom

Location

NORFOLK and Norwich University Hospital

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2020

First Posted

April 8, 2020

Study Start

January 22, 2021

Primary Completion

June 5, 2025

Study Completion

December 1, 2025

Last Updated

October 14, 2025

Record last verified: 2025-10

Locations

US(7)GB(3)