NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation
Laborie Medical Technologies Inc.
Summary
NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation to Confirm Ongoing Safety and Performance in Urodynamic Patient Sub-Populations
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
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
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 wom…
Interventions
- Diagnostic TestUrodynamic procedure
Urodynamic procedure
Locations (4)
- Chesapeake Urology HanoverHanover, Maryland
- Chesapeake Urology Owing MillsOwing Mills, Maryland
- Ohio State UniversityColumbus, Ohio
- University of VirginiaCharlottesville, Virginia