This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.
Study Type
OBSERVATIONAL
Enrollment
52
This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.
Tampa Marriott Water Street
Tampa, Florida, United States
Rhaeos, Inc.
Chicago, Illinois, United States
Northwest Special Recreation Association
Rolling Meadows, Illinois, United States
Study Device Sensitivity
Study device sensitivity will be calculated as TP / (TP + FN).
Time frame: Approximately 1 hour
Study Device Specificity
Study device specificity will be calculated as TN / (TN + FP)
Time frame: Approximately 1 hour
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