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

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT04011566
Status
Recruiting
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Conditions

  • Hydrocephalus, Normal Pressure

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ShuntCheck — DIAGNOSTIC_TEST
    The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.

Study Details

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.

Key Dates

Start date
Jun 11, 2019
Status verified
May 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: ShuntCheck
    Participants will be administered the ShuntCheck diagnostic test.

Primary Outcome Measure

Specificity of ShuntCheck test [ Time Frame: 15 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of South Florida Department of Neurological Surgery and Brain RepairTampaFlorida33606
Naomi Abel, MD
[email protected]
813 259-0904
Naomi Abel, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of South Florida Department of Neurological Surgery and Brain Repair· Tampa, FL

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