RecruitingNot ApplicableNCT04757116

Post-Market Study to Assess iTind Safety in Comparison to UroLift

A Post-Market, Prospective, Randomized, Controlled, Multicenter International Study to Assess the Safety of the Temporarily Implanted Nitinol Device (iTind) Compared to the UroLift® System in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH)

Sponsor

Olympus Corporation of the Americas

Enrollment

256 participants

Start Date

Sep 26, 2022

Study Type

INTERVENTIONAL

Conditions

Benign Prostatic Hyperplasia (BPH)

Summary

The study objective is to evaluate the efficacy and safety of the iTind device compared to UroLift.

Eligibility

Sex: MALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called UroLift and a medical device called iTind for people with benign prostatic hyperplasia (bph). The study is currently recruiting participants at 19 locations. People eligible for this study include men aged 50 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEiTind

The iTind is implemented for 5-7 days

PROCEDUREUroLift

UroLift is a minimally invasive procedure where permanent implants are placed in the prostate.

Locations(19)

Mayo Clinic Arizona

Phoenix, Arizona, United States

Arizona Urology Specialists

Tucson, Arizona, United States

Urology Associates of Central California

Fresno, California, United States

Golden State Urology

Sacramento, California, United States

NorthShore University Health System Research Institute

Evanston, Illinois, United States

Southeast Louisiana Veterans Health Care System

New Orleans, Louisiana, United States

Minnesota Urology

Woodbury, Minnesota, United States

The Urology Center

Omaha, Nebraska, United States

Pacific West Urology

Las Vegas, Nevada, United States

Feinstein Institutes for Medical Research / Northwell Health

Syosset, New York, United States

The Conrad Pearson Clinic

Germantown, Tennessee, United States

Midtown Urology Associates

Austin, Texas, United States

Houston Metro Urology

Houston, Texas, United States

The Urology Place

San Antonio, Texas, United States

Potomac Urology Center

Alexandria, Virginia, United States

Chelsea and Westminster Hospital

Isleworth, Middlesex, United Kingdom

Queen Margaret Hospital

Dunfermline, United Kingdom

Frimley Park Hospital

London, United Kingdom

Norfolk & Norwich University Hospital

Norwich, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04757116

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