Study of Median Lobe Prostatic UroLift Procedure

NeoTract

Status: Completed

Conditions: Benign Prostatic Hyperplasia (BPH)

Treatments: Device: UroLift System procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT02625545

CP00001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 45 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

45 participants in 1 patient group

UroLift System procedure

Experimental group

Description:

All eligible,enrolled subjects will undergo a UroLift procedure

Treatment:

Device: UroLift System procedure