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NCT04011566Recruiting

Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus

University of South Florida

Start Date

6/11/2019

Completion Date

11/1/2026

Summary

The purpose of the study is to determine if the ShuntCheck test can correctly identify flow or no flow in a ventriculoperitoneal shunt in patients with asymptomatic normal pressure hydrocephalus.

Eligibility Criteria

Age Range: 40 years to No maximum

Inclusion Criteria: * Asymptomatic men or women 40 years old or older and have a ventriculoperitoneal shunt placed for normal pressure hydrocephalus and are visiting for routine care. * Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker 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 ventriculoperitoneal 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