Diagnostic Accuracy of ShuntCheck Compared to Radionuclide Shunt: Patency in Patients With Normal Pressure Hydrocephalus

Diagnostic Accuracy of ShuntCheck Compared With Radionuclide Shunt Patency Test to Detect Shunt Flow Obstruction in Patients With Normal Pressure Hydrocephalus - A Cross-sectional Analytic Study

The purpose of this study is to assess the diagnostic accuracy of ShuntCheck compared with radionuclide shunt patency testing (SPS) to detect CSF shunt flow of NPH patients with suspected shunt obstruction.

Study Overview

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

Detailed Description

The purpose of this study is to assess the diagnostic accuracy of ShuntCheck compared with radionuclide shunt patency testing (SPS) to detect CSF shunt flow of NPH patients with suspected shunt obstruction.

• 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, MD; Phone Number: 813 8448544; 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: 40 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 NPH hydrocephalus research subjects who have a VP shunt with a single ventricular catheter implanted for adult hydrocephalus are suspected of shunt obstruction and are scheduled for a radionuclide SPS.

Description

Inclusion Criteria:

• Men or women 40 yo or older and have a VP shunt placed for NPH and are suspected of shunt obstruction.
• 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

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?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

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
Sensitivity of ShuntCheck compared to radionuclide shunt patency study	15 minutes
Negative Predictive Value of ShuntCheck compared to radionuclide shunt patency study	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): January 24, 2020
• 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: 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: Pro00041345

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