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NCT Number: NCT04309487

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

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.

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Key information

Conditions

Hydrocephalus, Normal Pressure Brain Diseases Central Nervous System Diseases Hydrocephalus Nervous System Diseases

Age range

40 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

Location status: Recruiting

Location contact

Konrad Bach, MD

CONTACT

[email protected]

813 259-8898

Naomi Abel, MD

CONTACT

[email protected]

813 259-0904

Naomi Abel, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

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

Inclusion criteria

  • Men or women 40 yo or older and have a VP shunt placed for NPH and are suspected of shunt obstruction.
  • 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

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. Sensitivity of ShuntCheck compared to radionuclide shunt patency study

    Time frame: 15 minutes

  2. Negative Predictive Value of ShuntCheck compared to radionuclide shunt patency study

    Time frame: 60 Minutes

Study contacts

Contact information is provided by the study sponsor or research team.

Naomi Abel, MD

CONTACT

[email protected]

813 259-0904

Thanh Tran, MD

CONTACT

[email protected]

813 8448544

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • NeuroDx Development

Registry information

Official study title

Diagnostic Accuracy of ShuntCheck Compared With Radionuclide Shunt Patency Test to Detect Shunt Flow Obstruction in Patients With Normal Pressure Hydrocephalus - A Cross-sectional Analytic Study

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
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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