Diagnostic Accuracy of ShuntCheck Compared to Radionuclide Shunt: Patency in Patients With Normal Pressure Hydrocephalus
Diagnostic Accuracy of ShuntCheck Compared With Radionuclide Shunt Patency Test to Detect Shunt Flow Obstruction in Patients With Normal Pressure Hydrocephalus - A Cross-sectional Analytic Study
University of South Florida
20 participants
Jan 24, 2020
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- 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 Criteria3
- 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.
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Interventions
The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04309487