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

NeoTract

Status: Completed

Conditions: Benign Prostatic Hyperplasia

Treatments: Device: UroLift® System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01876706

CP12911

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH)

Exclusion criteria

• Size, volume,length of prostate

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

UroLift® System

Experimental group

Description:

Single-arm of qualified subjects receiving UroLift® System intervention.

Treatment:

Device: UroLift® System