Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04011566

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

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.

Recruiting

Interested in participating?

Request Info

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

Naomi Abel, MD

CONTACT

[email protected]

813 259-0904

Naomi Abel, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Asymptomatic men or women 40 years old or older and have a ventriculoperitoneal shunt placed for normal pressure hydrocephalus and are visiting for routine care.
  • Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker 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 ventriculoperitoneal 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

Study contacts

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

Naomi Abel, MD

CONTACT

[email protected]

813 259-0904

Rachel Karlnoski, MD

CONTACT

[email protected]

813 974 8558

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • NeuroDx Development

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jul 8, 2019
Registry last updated
May 19, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.