The purpose of this study is to assess the diagnostic accuracy of ShuntCheck compared with radionuclide shunt patency testing (SPS) to detect CSF shunt flow of NPH patients with suspected shunt obstruction.
Men or women 40 yo or older and have a VP shunt placed for NPH and are suspected of shunt obstruction.
Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol) capable of providing valid, signed informed consent
Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction;
ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated;
Presence of an interfering open wound or edema over any portion of the VP shunt.
The study population will consist of NPH hydrocephalus research subjects who have a VP shunt with a single ventricular catheter implanted for adult hydrocephalus are suspected of shunt obstruction and are scheduled for a radionuclide SPS.
Cohort
Cross-sectional
ShuntCheck
Diagnostic testThe intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.
Sensitivity of ShuntCheck compared to radionuclide shunt patency study
Negative Predictive Value of ShuntCheck compared to radionuclide shunt patency study
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University of South Florida
Lead sponsor
NeuroDx Development
Collaborator
