RecruitingNCT04011566
Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus
Sponsor
University of South Florida
Enrollment
50 participants
Start Date
Jun 11, 2019
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 40 Years
Inclusion Criteria2
- 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 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 ventriculoperitoneal shunt.
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Interventions
DIAGNOSTIC_TESTShuntCheck
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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NCT04011566