NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation to Confirm Ongoing Safety and Performance in Urodynamic Patient Sub-Populations
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.
Study Type
OBSERVATIONAL
Enrollment
180
Urodynamic procedure
Chesapeake Urology Hanover
Hanover, Maryland, United States
RECRUITINGChesapeake Urology Owing Mills
Owing Mills, Maryland, United States
RECRUITINGOhio State University
Columbus, Ohio, United States
RECRUITINGAssess NXT system performance
Assess the proportion of affirmative responses to the question: did the NXT system successfully measure all necessary urodynamic parameters you required for this patient?
Time frame: 120 Minutes
Assess NXT system safety
The primary safety endpoint will be measured by recording the incidence of serious adverse events and adverse events.
Time frame: 120 Minutes
Assess NXT system performance
Assess the proportion of affirmative responses to the question: Was the urodynamic study completed without any technical failure that prevented its completion?
Time frame: 120 Minutes
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University of Virginia
Charlottesville, Virginia, United States
RECRUITING