Comparing UroLift Experience Against Rezūm (CLEAR)

  • STATUS
    Recruiting
  • End date
    Dec 22, 2023
  • participants needed
    120
  • sponsor
    NeoTract, Inc.
Updated on 22 April 2022
obstruction
benign prostatic hyperplasia
hyperplasia
Accepts healthy volunteers

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.

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.

Details
Condition Benign Prostatic Hyperplasia
Treatment UroLift, Rezum
Clinical Study IdentifierNCT04338776
SponsorNeoTract, Inc.
Last Modified on22 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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