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.

Study Overview

• Status: Recruiting
• Conditions: Hydrocephalus, Normal Pressure
• Intervention / Treatment: Diagnostic test: ShuntCheck

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Naomi Abel, MD; Phone Number: 813 259-0904; Email: nabel@usf.edu
• Study Contact Backup: Name: Rachel Karlnoski, MD; Phone Number: 813 974 8558; Email: Karlnosk@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@health.usf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population will consist of asymptomatic normal pressure hydrocephalus research subjects who have a ventriculoperitoneal shunt with a single ventricular catheter implanted for adult hydrocephalus and are visiting for routine care. Evaluation will be within 2 weeks of shunt placement.

Description

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.

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): June 11, 2019
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 8, 2019

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Ventriculoperitoneal Shunt; Asymptomatic Normal Pressure Hydrocephalus
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus; Hydrocephalus, Normal Pressure
• Other Study ID Numbers: Pro00040697

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: individual participant data that underlies the results reported after deidentification and statistical analysis will be shared following publication for 5 years with researchers who provide a methodologically sound proposal
• IPD Sharing Time Frame: individual participant data that underlies the results reported after deidentification and statistical analysis will be shared following publication for 5 years with researchers who provide a methodologically sound proposal
• IPD Sharing Access Criteria: data use agreement required and methodologically sound proposal
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No