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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

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Conditions

Hydrocephalus, Normal Pressure

Locations

University of South Florida Department of Neurological Surgery and Brain Repair

Tampa, Florida 33606

United States