This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of known non-functional and functional implanted shunts will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.
Study Type
OBSERVATIONAL
Enrollment
10
This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of known non-functional and functional implanted shunts will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.
CHOC Commerce Tower
Orange, California, United States
Cedars-Sinai Accelerator
West Hollywood, California, United States
Tampa Marriott Water Street
Tampa, Florida, United States
MATTER
Chicago, Illinois, United States
Study Device Sensitivity
Study device sensitivity will be calculated as TP / (TP + FN).
Time frame: Up to 1 hour
Study Device Specificity
Study device specificity will be calculated as TN / (TN + FP)
Time frame: Up to 1 hour
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Industrious
Evanston, Illinois, United States
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Texas Medical Center Innovation
Houston, Texas, United States
Industrious
Seattle, Washington, United States