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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 1-week
Awards & highlights

CLEAR Trial 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.Check my eligibility
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.See study design
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.

CLEAR Trial 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.
Select...
I am 50 years old or older.
Select...
My prostate size is between 30cm3 and 80cm3.
Select...
I am male.

CLEAR Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Catheter Independent

CLEAR 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to participate in this investigation if one meets the criteria?

"Affirmative. The details available on clinicaltrials.gov demonstrate that this medical research, which was originally posted in January 2021, is actively recruiting participants. A total of 120 individuals will be recruited across 4 healthcare centres."

Answered by AI

How many people are involved in this trial?

"That is accurate. According to clinicaltrials.gov, this medical research was initially published on January 22nd 2021 and has since been updated on March 28th 2022. The study needs 120 volunteers from 4 different sites in order to be completed successfully."

Answered by AI

What is the geographical breadth of this clinical experiment?

"This medical trial is taking place at 4 distinct centres, situated in San Antonio, Garden City and New york with an additional 4 sites. To reduce travel inconveniences it may be beneficial to choose the clinic closest to you if you opt-in for enrolment."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Urology Austin
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I am considering my options to treat BPH. I just started evaluating Rezum, Aquablution, and other possible experimental treatments.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Comparing UroLift Experience Against Rezūm
2021. "Comparing UroLift Experience Against Rezūm". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04338776.
All > Benign Prostatic Hyperplasia > Bph
~18 spots leftby Dec 2024
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