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
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