University of South Florida
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.
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.
Inclusion Criteria: * 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 Exclusion Criteria: * 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;…
The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.
Arctuva estimate
Verify or correct the compensation shown for this listing.