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NCT06336304Recruiting

NXT Post-Market Clinical Follow-up

Laborie Medical Technologies Inc.

Start Date

6/18/2024

Completion Date

3/1/2027

Summary

NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation to Confirm Ongoing Safety and Performance in Urodynamic Patient Sub-Populations

Detailed Description

The primary objective of this study is to confirm the safety and performance of NXT urodynamic system for the intended patient populations, medically indicated for urodynamic study.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: * Patients medically indicated for urodynamic study * Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements Exclusion Criteria: * Patients or legally authorized representative with cognitive or psychiatric condition that interferes with or precludes direct and accurate communication regarding the study, giving informed consent or ability to complete the patient questionnaire * Patients with confirmed active bladder infections (not including patients with asymptotic bacteria) * Pregnant women * Patients with recent (less than 2 weeks) pelvic floor surgery * Requires use of suprapubic catheter

Interventions

DIAGNOSTIC_TEST

Urodynamic procedure

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Conditions

Urinary IncontinenceUrinary ObstructionUrinary Bladder, OveractiveUrinary Bladder, NeurogenicUrinary Incontinence, Urge

Locations

Chesapeake Urology Hanover

Hanover, Maryland 21076

United States

Chesapeake Urology Owing Mills

Owing Mills, Maryland 21117

United States

Nationwide Children's Hospital

Columbus, Ohio 43205

United States

Ohio State University

Columbus, Ohio 43212

United States

University of Virginia

Charlottesville, Virginia 22903

United States