ShuntCheck Performance Characteristics in Asymptomatic Pseudotumor Cerebri Patients

Pseudotumor Cerebri Clinical Trial

Official title:

Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Pseudotumor Cerebri

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04309383
• Other study ID #: Pro00042422
• Status: Recruiting
• Start date: October 29, 2019
• Est. completion date: January 2025

Study information

• Verified date: May 2022
• Source: University of South Florida
• Contact: Naomi Abel, MD
• Phone: 813 259-0904
• Email: nabel[@]usf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2025
• Est. primary completion date: June 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pseudotumor Cerebri

Intervention

Diagnostic Test:
• ShuntCheck
The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.

Locations

Country	Name	City	State
United States	University of South Florida Department of Neurological Surgery and Brain Repair	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	NeuroDx Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specificity of ShuntCheck test		15 minutes
Primary	Negative Predictive Value of ShuntCheck test		15 minutes
Secondary	Specificity of performing ShuntCheck test twice		60 minutes
Secondary	Negative Predictive Value of performing ShuntCheck test twice		60 minutes