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

Hydrocephalus, Normal Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04309487
• Other study ID #: Pro00041345
• Status: Recruiting
• Start date: January 24, 2020
• 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2025
• Est. primary completion date: June 2024
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hydrocephalus
• Hydrocephalus, Normal Pressure

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	Sensitivity of ShuntCheck compared to radionuclide shunt patency study		15 minutes
Primary	Negative Predictive Value of ShuntCheck compared to radionuclide shunt patency study		60 Minutes