CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 51 enrolled
Drug / intervention
UroLift® Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01876706
NCT01876706N/ACompleted
CompareCT.gov

L.O.C.A.L. Study -- UroLift System TOlerability and ReCovery When Administering Local Anesthesia

NeoTract, Inc.·interventional·Posted Jun 13, 2013·Updated Mar 20, 2019

In Brief

A clinical study evaluating UroLift® System for Benign Prostatic Hyperplasia. Completed, enrolled 51 participants across 7 sites.

Detailed Summary

The purpose of the study is to evaluate procedure tolerability and surgical recovery following the UroLift® system procedure when conducted with local anesthesia in subjects with symptomatic benign hyperplasia (BPH). Primary effectiveness will be achieved by looking at the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBenign Prostatic Hyperplasia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 13, 2013
Enrollment StartApr 1, 2013
Primary CompletionOct 1, 2014
Study CompletionSep 4, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 13.1 years ago

Interventions

UroLift® Systemdevice

The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, and Canada. The UroLift® System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older. During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra.