ShuntCheck Performance Characteristics in Asymptomatic Pseudotumor Cerebri Patients

Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Pseudotumor Cerebri

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04309383

Enrollment

Registered

2020-03-16

Start date

2019-10-29

Completion date

2026-02-05

Last updated

2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pseudotumor Cerebri

Keywords

Pseudotumor Cerebri, Ventriculoperitoneal Shunt

Brief 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 pseudotumor cerebri.

Detailed description

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

Interventions

DIAGNOSTIC_TESTShuntCheck

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

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Specificity of ShuntCheck test	15 minutes
Negative Predictive Value of ShuntCheck test	15 minutes

Secondary

Measure	Time frame
Specificity of performing ShuntCheck test twice	60 minutes
Negative Predictive Value of performing ShuntCheck test twice	60 minutes

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORNaomi Abel, MD

University of South Florida

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026