UroLift System TOlerability and ReCovery When Administering Local Anesthesia (LOCAL)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
NeoTract, Inc.
ClinicalTrials.gov Identifier:
NCT01876706
First received: May 6, 2013
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

The purpose of the study is to evaluate procedure tolerability and surgical recovery following the UroLift® system procedure when conducted with local anesthesia in subjects with symptomatic benign hyperplasia (BPH). Primary effectiveness will be achieved by looking at the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit.


Condition Intervention
Benign Prostatic Hyperplasia
Device: UroLift® System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: L.O.C.A.L. Study -- UroLift System TOlerability and ReCovery When Administering Local Anesthesia

Resource links provided by NLM:


Further study details as provided by NeoTract, Inc.:

Primary Outcome Measures:
  • Quality of Recovery [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
    Primary effectiveness will be achieved when 80% (95% lower confidence limit) of subjects achieve a score of 80 or more on the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit.


Secondary Outcome Measures:
  • Resolution of BPH, Procedural Recovery Measures, and Health Economics [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    Over the 12 month follow-up period, lower urinary tract symptoms (LUTS), quality of life (QOL), uroflowmetry, sexual function, pain tolerability of procedure, health economic data, patient satisfaction and device related adverse events will be assessed.


Enrollment: 51
Study Start Date: April 2013
Estimated Study Completion Date: September 2018
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: UroLift® System
Single-arm of qualified subjects receiving UroLift® System intervention.
Device: UroLift® System
The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, and Canada. The UroLift® System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older. 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.

Detailed Description:

The randomized portion of the study is a prospective, multicenter, non-blinded, single arm trial evaluating procedure tolerability and surgical recovery following the UroLift® system procedure when conducted with local anesthesia. All subjects undergo UroLift system treatment and will be followed through 5 years after receiving 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01876706

Locations
United States, California
Premier Urology/San Diego Uro-Research
San Diego, California, United States, 92103
United States, Florida
Atlantic Urological Associates
Daytona Beach, Florida, United States, 32114
Pinellas Urology
St. Petersburg, Florida, United States, 33710
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, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
NeoTract, Inc.
  More Information

No publications provided

Responsible Party: NeoTract, Inc.
ClinicalTrials.gov Identifier: NCT01876706     History of Changes
Other Study ID Numbers: CP12911
Study First Received: May 6, 2013
Last Updated: February 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by NeoTract, Inc.:
UroLift System

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male

ClinicalTrials.gov processed this record on September 18, 2014