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Prostate Treatment Device

Rezum vs UroLift for Enlarged Prostate (CLEAR Trial)

N/A
Recruiting
Research Sponsored by NeoTract, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of symptomatic BPH
Age ≥ 50 years
Must not have
Current gross hematuria
Urethra conditions that may prevent insertion of delivery system into bladder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 1-week
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the side effects and long-term effectiveness of two common treatments for enlarged prostate.

Who is the study for?
Men over 50 with symptoms of an enlarged prostate (30cm3 to 80cm3 in size) who haven't had previous BPH surgery, don't have a urinary infection or severe bleeding, and aren't part of another study. Those with certain urethra conditions, a penile prosthesis, or urinary sphincter implant are excluded.
What is being tested?
The C.L.E.A.R. Study is comparing two minimally invasive procedures for enlarged prostate: UroLift and Rezūm. It focuses on patient experience after the procedure regarding the need for catheterization, retreatment rates, and use of BPH medications over a year.
What are the potential side effects?
Potential side effects from UroLift and Rezūm treatments can include discomfort during urination, blood in urine, frequent urination urges shortly after the procedure, possible need for re-treatment or medication for persistent symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with an enlarged prostate causing symptoms.
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I am 50 years old or older.
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My prostate size is between 30cm3 and 80cm3.
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I am male.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently experiencing blood in my urine.
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I have a condition that might prevent medical instruments from being inserted into my bladder.
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I currently have a urinary tract infection.
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I have had surgery for an enlarged prostate.
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I have urinary incontinence due to a weak bladder sphincter.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 1-week
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 1-week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Catheter Independent

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: UroLiftExperimental Treatment1 Intervention
Patient randomized to the UroLift arm will receive the FDA-approved UroLift procedure.
Group II: RezūmExperimental Treatment1 Intervention
Patient randomized to the Rezūm arm will receive the FDA-approved Rezūm procedure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
UroLift
2018
N/A
~20

Find a Location

Who is running the clinical trial?

NeoTract, Inc.Lead Sponsor
10 Previous Clinical Trials
3,280 Total Patients Enrolled

Media Library

Rezum (Prostate Treatment Device) Clinical Trial Eligibility Overview. Trial Name: NCT04338776 — N/A
Enlarged Prostate Clinical Trial 2023: Rezum Highlights & Side Effects. Trial Name: NCT04338776 — N/A
Rezum (Prostate Treatment Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04338776 — N/A
Enlarged Prostate Patient Testimony for trial: Trial Name: NCT04338776 — N/A
~9 spots leftby May 2025
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