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Urodynamic Feasibility Study Utilizing the UroLift® System

NCT04271020 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-06-11

Study results available
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Summary

UDS evaluates the impact of Prostatic Urethral Lift (PUL) as measured by pressure flow, urodynamic testing (UDS) and an optional UroCuff Testing, an alternative urodynamic test. In addition, standard BPH measures such as symptoms, qualify of life, uroflowmetry, and post void residual will be evaluated at screening and at the follow-up visits.

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DEVICE

UroLift

The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH). 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.

Sponsors & Collaborators

  • NeoTract, Inc.

    lead INDUSTRY

Principal Investigators

  • Brian Mazzarella, MD · Midtown Urology Associates

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-25
Primary Completion
2019-04-22
Completion
2019-11-27
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04271020 on ClinicalTrials.gov