ShuntCheck Performance Characteristics in Asymptomatic Pseudotumor Cerebri Patients

Recruiting

• Conditions: Pseudotumor Cerebri
• Interventions: Diagnostic Test: ShuntCheck

• Registration Number: NCT04309383
• Lead Sponsor: University of South Florida

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

Study Timeline

• Study Start: 2019-10-29
• Study First Submitted: 2020-03-12
• Study First Submitted QC: 2020-03-12
• Study First Posted: 2020-03-16
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-30
• Last Update Posted: 2022-06-01
• Primary Completion: 2024-06
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ShuntCheck	ShuntCheck	Participants will be administered the ShuntCheck diagnostic test.

Primary Outcome Measures

Name	Time	Method
Specificity of ShuntCheck test	15 minutes
Negative Predictive Value of ShuntCheck test	15 minutes

Secondary Outcome Measures

Name	Time	Method
Negative Predictive Value of performing ShuntCheck test twice	60 minutes
Specificity of performing ShuntCheck test twice	60 minutes

Trial Locations

Locations (1)

University of South Florida Department of Neurological Surgery and Brain Repair; 🇺🇸 Tampa, Florida, United States