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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: Completed NA study of Benign Prostatic Hyperplasia, sponsored by NeoTract.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary safety endpoint is an assessment of the rate of extended post-operative urinary catheterization in the subjects randomized to the UroLift group of the study in the ITT group. The extended post-operative urinary catheterization rate is defined as including those subjects who required catheterization within the first 3 days as part of post-operative management for inability to void, and required the catheter for more than 7 days. 2/140 met this endpoint.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2011-02 |
| Est. Completion | 2017-07-05 |
| Phase | NA |
What the finished NCT01294150 record still lists
NCT01294150 is an interventional study that assigns participants to a tested intervention. The registered 206 participants enrollment target is mid-sized for trials with a published cap, below the 545-participant average among 29 other Benign Prostatic Hyperplasia trials with a reported enrollment target (62% lower).
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 lists 19 locations in 15 states (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.
Learn More About Clinical Trials
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Where NCT01294150's enrollment target sits among peer trials
206 11th of 29 higher than 19 of 29 other Benign Prostatic Hyperplasia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Benign Prostatic Hyperplasia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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