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Completed

NCT Number: NCT04309383

ShuntCheck Performance Characteristics in Asymptomatic Pseudotumor Cerebri Patients

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 pseudotumor cerebri.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of South Florida Department of Neurological Surgery and Brain Repair

Tampa, Florida, 33606, United States

About this study

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 pseudotumor cerebri.

Flow may be limited due to slit ventricles

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years old or older Adult men or women who possess a VP shunt placed for PTC;
  • Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol) capable of providing valid, signed informed consent;
  • Subjects will be asymptomatic visiting for routine care at 2-4 weeks post op

Exclusion criteria

  • Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction;
  • 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 VP shunt.

Treatment and study plan

ShuntCheck

Diagnostic Test

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

Primary outcomes

  1. Specificity of ShuntCheck test

    Time frame: 15 minutes

  2. Negative Predictive Value of ShuntCheck test

    Time frame: 15 minutes

Secondary outcomes

  1. Specificity of performing ShuntCheck test twice

    Time frame: 60 minutes

  2. Negative Predictive Value of performing ShuntCheck test twice

    Time frame: 60 minutes

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • NeuroDx Development

Registry information

Official study title

Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Pseudotumor Cerebri

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2020
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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