Status:
ACTIVE_NOT_RECRUITING
Comparing UroLift Experience Against Rezūm
Lead Sponsor:
NeoTract, Inc.
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
50+ years
Phase:
NA
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...
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 voidi...
Eligibility Criteria
Inclusion
- Male gender
- Age ≥ 50 years
- Diagnosis of symptomatic BPH
- Prostate volume 30cm3 ≤ 80cm3
- Willing to sign study informed consent form
Exclusion
- 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
Key Trial Info
Start Date :
January 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04338776
Start Date
January 22 2021
End Date
December 1 2025
Last Update
October 14 2025
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Tower Urology
Los Angeles, California, United States, 90048
2
Comprehensive Urology
Royal Oak, Michigan, United States, 48073
3
NYU Winthrop Urology
Garden City, New York, United States, 11530
4
Weil Cornell Medical College, Cornell University
New York, New York, United States, 10065