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The purpose of this study is to evaluate the safety and effectiveness of using UroLift in subjects with a prostatic median lobe enlargement due to benign prostatic hyperplasia (BPH).
Study Objectives: Evaluate the safety and effectiveness of the UroLift® System when used in symptomatic benign prostatic hyperplasia (BPH) subjects with an enlarged median lobe. Study Design: Prospective, multicenter, non-blinded, single arm (non-randomized) study. Sample Size: A total of no more than 48 subjects will be enrolled. Subject Population: Males age of 50 years or older diagnosed with lower urinary tract symptoms (LUTS) with enlarged median lobe.
Age
50 - No limit years
Sex
MALE
Healthy Volunteers
No
Start Date
February 17, 2016
Primary Completion Date
May 30, 2017
Completion Date
December 19, 2017
Last Updated
February 26, 2019
45
ACTUAL participants
UroLift System procedure
DEVICE
Lead Sponsor
NeoTract, Inc.
NCT07016620
NCT06817733
NCT02026908
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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