Trials / Completed
CompletedNCT02625545
Study of Median Lobe Prostatic UroLift Procedure
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- NeoTract, Inc. · Industry
- Sex
- Male
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and effectiveness of using UroLift in subjects with a prostatic median lobe enlargement due to benign prostatic hyperplasia (BPH).
Detailed description
Study Objectives: Evaluate the safety and effectiveness of the UroLift® System when used in symptomatic benign prostatic hyperplasia (BPH) subjects with an enlarged median lobe. Study Design: Prospective, multicenter, non-blinded, single arm (non-randomized) study. Sample Size: A total of no more than 48 subjects will be enrolled. Subject Population: Males age of 50 years or older diagnosed with lower urinary tract symptoms (LUTS) with enlarged median lobe.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | UroLift System procedure | Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH |
Timeline
- Start date
- 2016-02-17
- Primary completion
- 2017-05-30
- Completion
- 2017-12-19
- First posted
- 2015-12-09
- Last updated
- 2019-02-26
- Results posted
- 2019-02-26
Source: ClinicalTrials.gov record NCT02625545. Inclusion in this directory is not an endorsement.