Stopped: Slow Enrollment, Recruiting Difficulties
This is a retrospectively-controlled clinical trial that will examine the rate of positive UTI cases among pediatrics entered into the Emergency Department and whose urine is withdrawn using the PedSCath Pediatric Sampling Catheter. The rate of postive UTI will be compared against the control population, whose urine withdrawal would have been performed with Standard of Care devices.
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The primary effectiveness endpoint is the proportion of PedSCath subjects with positive UTI diagnosis versus that of Control subjects.
Timeframe: Through study completion, an estimation of 1 year.