Diagnostic Accuracy of ShuntCheck Compared to Radionuclide Shunt: Patency in Patients With Normal Pressure Hydrocephalus

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT04309487
Status
Recruiting
Apply to this trial

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 this study is to assess the diagnostic accuracy of ShuntCheck compared with radionuclide shunt patency testing (SPS) to detect CSF shunt flow of NPH patients with suspected shunt obstruction.

Key Dates

Start date
Jan 24, 2020
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
20 participants (estimated)

Arms

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

Primary Outcome Measure

Sensitivity of ShuntCheck compared to radionuclide shunt patency study [ 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
Konrad Bach, MD
[email protected]
813 259-8898
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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