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

NCT04309487 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-05-18

No results posted yet for this study

Summary

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.

Conditions

  • Hydrocephalus, Normal Pressure

Interventions

DIAGNOSTIC_TEST

ShuntCheck

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

Sponsors & Collaborators

  • University of South Florida

    lead OTHER

  • NeuroDx Development

    collaborator INDUSTRY

Principal Investigators

  • Naomi Abel, MD · University of South Florida

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-24
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04309487 on ClinicalTrials.gov