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

NCT04011566 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-05-19

No results posted yet for this study

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.

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

  • NeuroDx Development

    collaborator INDUSTRY

  • University of South Florida

    lead OTHER

Principal Investigators

  • Naomi Abel, MD · University of South Florida

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-11
Primary Completion
2026-11-30
Completion
2026-11-30

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 NCT04011566 on ClinicalTrials.gov