Status:
UNKNOWN
Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus
Lead Sponsor:
University of South Florida
Collaborating Sponsors:
NeuroDx Development
Conditions:
Hydrocephalus, Normal Pressure
Eligibility:
All Genders
40+ years
Brief 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
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 11 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04011566
Start Date
June 11 2019
End Date
January 1 2025
Last Update
September 30 2022
Active Locations (1)
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1
University of South Florida Department of Neurological Surgery and Brain Repair
Tampa, Florida, United States, 33606