ShuntCheck Performance Characteristics in Asymptomatic Pseudotumor Cerebri Patients

Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Pseudotumor Cerebri

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.

Study Overview

• Status: Recruiting
• Conditions: Pseudotumor Cerebri
• Intervention / Treatment: Diagnostic test: ShuntCheck

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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Naomi Abel, MD; Phone Number: 813 259-0904; Email: nabel@usf.edu
• Study Contact Backup: Name: Thanh Tran; Phone Number: 813 844 8544; Email: tqtran@usf.edu

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Recruiting
      • University of South Florida Department of Neurological Surgery and Brain Repair
      • Principal Investigator: Naomi Abel, MD
      • Contact: Naomi Abel, MD; Phone Number: 813-259-0904; Email: nabel@usf.edu
      • Contact: Konrad Bach, MD; Phone Number: 813 259-8898; Email: kbach@usf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population will consist of asymptomatic PTC research subjects who have a VP shunt with a single ventricular catheter implanted for PTC and are visiting for routine care.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ShuntCheck; Participants will be administered the ShuntCheck diagnostic test.	Diagnostic test: ShuntCheck; The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Specificity of ShuntCheck test	15 minutes
Negative Predictive Value of ShuntCheck test	15 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of South Florida
• Collaborators: NeuroDx Development
• Investigators: Principal Investigator: Naomi Abel, MD, University of South Florida

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2019
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (Actual): March 16, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Pseudotumor Cerebri, Ventriculoperitoneal Shunt
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hypertension; Pseudotumor Cerebri
• Other Study ID Numbers: Pro00042422

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: At present there is no plan to share any individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No