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NCT01294150 · ClinicalTrials.gov registry record · NA

The Safety and Effectiveness of UroLift: LIFT Pivotal Study

A NA study of Benign Prostatic Hyperplasia, sponsored by NeoTract.

Completed
Registry status
NA
Development phase
206
Enrollment target
19
Study locations

NCT01294150 is a NA study of Benign Prostatic Hyperplasia that has completed, run by NeoTract. The registered enrollment target is 206 participants, below the 545-participant average among 29 other Benign Prostatic Hyperplasia trials with a reported enrollment target (62% lower). The trial reports 19 study locations across 15 states.

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The verdict

NCT01294150, a NA study of Benign Prostatic Hyperplasia, has completed, sponsored by NeoTract.

COMPLETED
Registry status
NA
Development phase
206 participants
Enrollment target
19
Study locations

Study 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.

Interventions

  • DEVICE UroLift System
  • OTHER Cystoscopy
  • DEVICE Crossover

Study Locations (19)

California

  • Genesis Research LLC - San Diego
  • Shahram S. Gholami MD - A Professional Corp. - San Jose

Florida

  • Advanced Urology Institute - Daytona Beach
  • Pinellas Urology - St. Petersburg

Texas

  • UT Southwestern Medical Center - Dallas
  • Scott and White Healthcare - Temple

Ontario

  • Oakville Trafalgar Memorial Hospital - Oakville
  • Cam Am HIFU - Toronto

Colorado

  • Urology Associates of Denver - Englewood

Illinois

  • Northwestern University - Chicago

Maryland

  • Chesapeake Urology - Baltimore

Nevada

  • Sheldon J. Freedman, M.D., Ltd. - Las Vegas

Trial Details

FieldValue
Enrollment Target 206 participants
Start Date 2011-02
Est. Completion 2017-07-05
Phase NA

Sponsor

NeoTract

4 total trials

What the Registry Record Tells You About NCT01294150

The ClinicalTrials.gov registry entry for NCT01294150 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 206 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 545-participant average among 29 other Benign Prostatic Hyperplasia trials with a reported enrollment target (62% lower). The listed sponsor is NeoTract, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Benign Prostatic Hyperplasia appearing as the primary indexed condition, and to 3 interventions - of which UroLift System is the first listed.

NCT01294150 reports 19 study locations spanning 15 distinct geographic areas - top geographies include California, Florida, Texas.

Frequently Asked Questions

What is clinical trial NCT01294150 about?

NCT01294150 is a clinical study titled "The Safety and Effectiveness of UroLift: LIFT Pivotal Study". 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 review...

What is the current status of trial NCT01294150?

This trial is currently completed. It is a NA study. The enrollment target is 206 participants. The study started on 2011-02. Estimated completion is 2017-07-05.

What conditions does trial NCT01294150 study?

This clinical trial studies the following conditions: Benign Prostatic Hyperplasia.

What interventions are being tested in trial NCT01294150?

The interventions under investigation include: UroLift System (DEVICE), Cystoscopy (OTHER), Crossover (DEVICE).

Who is sponsoring clinical trial NCT01294150?

This trial is sponsored by NeoTract, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01294150 being conducted?

This trial has 19 study locations across California, Colorado, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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