Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus
NCT ID: NCT04011566
Last Updated: 2022-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2019-06-11
2025-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ShuntCheck
Participants will be administered the ShuntCheck diagnostic test.
ShuntCheck
The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.
Interventions
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ShuntCheck
The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
ALL
No
Sponsors
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NeuroDx Development
INDUSTRY
University of South Florida
OTHER
Responsible Party
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Naomi Abel
Assistant Professor, College of Medicine Neurosurgery
Principal Investigators
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Naomi Abel, MD
Role: PRINCIPAL_INVESTIGATOR
University of South Florida
Locations
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University of South Florida Department of Neurological Surgery and Brain Repair
Tampa, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pro00040697
Identifier Type: -
Identifier Source: org_study_id
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