Study of Median Lobe Prostatic UroLift Procedure

Study of Median Lobe Prostatic UroLift Procedure

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).

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.

Inclusion Criteria:

• Enlarged median lobe (ML) contributing to obstruction of the prostate
• BPH

Exclusion Criteria:

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