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The Safety and Effectiveness of UroLift: LIFT Pivotal Study — LIFT  

Benign Prostatic Hyperplasia Clinical Trial

Official title:
Luminal Improvement Following Prostatic Tissue Approximation for the Treatment of Lower Urinary Tract Symptoms

Clinical Trial Summary

The purpose of the study is to evaluate the safety and effectiveness of the UroLift(R) System when used in subjects with symptomatic benign hyperplasia (BPH). Primary effectiveness will be achieved by looking at the improvement of International Prostate Symptom Score (IPSS) and safety will be reviewed based on pertinent adverse events.

Clinical Trial Description

The randomized portion of the study is a prospective, multicenter, multinational, 2:1 randomized, single-blinded controlled clinical trial comparing the IPSS of the treatment group to the IPSS of the control group at the 3 month follow-up. Subjects in the active treatment group undergo UroLift system treatment. Subjects in the control group undergo a cystoscopy procedure.

All subjects will be followed through 12 months, and through 5 years for those that receive the investigational device. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01294150
Study type Interventional
Source NeoTract, Inc.
Contact
Status Completed
Phase N/A
Start date February 2011
Completion date July 5, 2017
View Details
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