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The Safety and Effectiveness of UroLift: LIFT Pivotal Study
NCT01294150 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01294150
The ClinicalTrials.gov registry entry for NCT01294150 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 206 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NeoTract, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01294150 reports 19 study locations spanning 15 distinct geographic areas — top geographies include California, Florida, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01294150?
The interventions under investigation include: UroLift System (DEVICE), Cystoscopy (OTHER), Crossover (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01294150?
This trial is sponsored by NeoTract, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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