NCT04309487Recruiting
Diagnostic Accuracy of ShuntCheck Compared to Radionuclide Shunt: Patency in Patients With Normal Pressure Hydrocephalus
University of South Florida
Start Date
1/24/2020
Completion Date
1/1/2027
Summary
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.
Detailed Description
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.
Eligibility Criteria
Age Range: 40 years to No maximum
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;
* 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.
Interventions
DIAGNOSTIC_TEST
ShuntCheck
Conditions
Hydrocephalus, Normal Pressure
Locations
University of South Florida Department of Neurological Surgery and Brain Repair
Tampa, Florida 33606
United States