The Safety and Effectiveness of UroLift: LIFT Pivotal Study
This study is ongoing, but not recruiting participants.
Sponsor:
NeoTract, Inc.
Information provided by (Responsible Party):
NeoTract, Inc.
ClinicalTrials.gov Identifier:
NCT01294150
First received: February 7, 2011
Last updated: January 28, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Benign Prostatic Hyperplasia |
Device: UroLift(R) System Other: Cystoscopy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Luminal Improvement Following Prostatic Tissue Approximation for the Treatment of Lower Urinary Tract Symptoms |
Resource links provided by NLM:
Further study details as provided by NeoTract, Inc.:
Primary Outcome Measures:
- Comparison of IPSS for Efficacy [ Time Frame: 3 month ] [ Designated as safety issue: No ]3 Month comparison between control and treatment arms of IPSS
- Collection of post-treatment catheterization for safety [ Time Frame: > 7 days ] [ Designated as safety issue: Yes ]Post-procedure catheterization will be collected.
- IPSS improvement of UroLift patients for efficacy [ Time Frame: 12 months ] [ Designated as safety issue: No ]12 month comparison to baseline IPSS scores.
| Enrollment: | 206 |
| Study Start Date: | February 2011 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: UroLift System
The treatment group subjects will undergo the UroLift system procedure. The subject will be blinded as to whether he is in the control or treatment group. Unblinding will occur at 3 months post procedure after the assessments are completed. Subjects treated with the UroLift system may experience return of LUTS. Between 3 and 12 month follow-up assessments, a subject may be retreated with the UroLift system if he meets the retreatment inclusion and exclusion criteria or treated with other approved therapies. Patients that go on for retreatment within the first 12 months will be considered treatment failures. No matter which retreatment therapy, all subjects will be followed at a minimum of 5 years per the assessment schedule.
|
Device: UroLift(R) System
The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). 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.
|
|
Sham Comparator: Control
The control group subjects will undergo a cystoscopy procedure. The subject will be blinded as to whether he is in the control or treatment group. Unblinding will occur at 3 months post procedure after follow-up assessments are completed. Subjects undergoing the cystoscopy procedure may experience return of LUTS. Between 3 and 12 month follow-up assessments, a subject may be treated with the UroLift system if he meets the retreatment inclusion and exclusion criteria. Subjects crossing over will then be followed for 5 years post-treatment. The subject can also be treated by other approved therapies after which follow-up through 12 months is required.
|
Other: Cystoscopy |
Detailed 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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH)
Exclusion Criteria:
- Size, volume,length of prostate
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294150
Locations
| United States, California | |
| SD Uro Research | |
| San Diego, California, United States, 92103 | |
| Good Samaritan Hospital | |
| San Jose, California, United States, 95124 | |
| United States, Colorado | |
| Urology Associates of Denver | |
| Englewood, Colorado, United States, 80113 | |
| United States, Florida | |
| Atlantic Urological Associates | |
| Daytona Beach, Florida, United States, 32114 | |
| Pinellas Urology | |
| St. Petersburg, Florida, United States, 33710 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Maryland | |
| Chesapeake Urology | |
| Baltimore, Maryland, United States, 21237 | |
| United States, Nevada | |
| Sheldon J. Freedman, M.D., Ltd. | |
| Las Vegas, Nevada, United States, 89148 | |
| United States, New York | |
| Weill Cornell Medical College | |
| New York, New York, United States, 10065 | |
| United States, Pennsylvania | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822 | |
| United States, South Carolina | |
| Carolina Urologic Research Center | |
| Myrtle Beach, South Carolina, United States, 29572 | |
| United States, Texas | |
| UT Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
| Scott and White Healthcare | |
| Temple, Texas, United States, 76504 | |
| United States, Utah | |
| Western Urological Clinic | |
| Salt Lake City, Utah, United States, 84107 | |
| Australia, New South Wales | |
| Figtree Hospital | |
| Figtree, New South Wales, Australia, 2525 | |
| Australia, Victoria | |
| Austin Hospital | |
| Heidelberg, Victoria, Australia | |
| Australia | |
| Port Macquarie Urology Centre | |
| Port Macquarie, Australia, 2444 | |
| Canada, Ontario | |
| Oakville Trafalgar Memorial Hospital | |
| Oakville, Ontario, Canada, L6J 3L7 | |
| The Cosmetic Surgery Hospital | |
| Woodbridge, Ontario, Canada, L4L 1S7 | |
Sponsors and Collaborators
NeoTract, Inc.
More Information
No publications provided
| Responsible Party: | NeoTract, Inc. |
| ClinicalTrials.gov Identifier: | NCT01294150 History of Changes |
| Other Study ID Numbers: | 1012CP |
| Study First Received: | February 7, 2011 |
| Last Updated: | January 28, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Australia: Department of Health and Ageing Therapeutic Goods Administration |
Additional relevant MeSH terms:
|
Prostatic Hyperplasia Hyperplasia Prostatic Diseases Genital Diseases, Male Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013