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
Conditions
Hydrocephalus, Normal Pressure
Locations
University of South Florida Department of Neurological Surgery and Brain Repair
Tampa, Florida 33606
United States