NCT01876706

UroLift System TOlerability and ReCovery When Administering Local Anesthesia

L.O.C.A.L. Study -- UroLift System TOlerability and ReCovery When Administering Local Anesthesia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: NeoTract, Inc. · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-10-01
• Completion: 2018-09-04
• First posted: 2013-06-13
• Last updated: 2019-03-20
• Results posted: 2015-11-25

Locations

7 sites across 1 country: United States