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

Recruiting

• Conditions: Hydrocephalus, Normal Pressure
• Interventions: Diagnostic Test: ShuntCheck

• Registration Number: NCT04309487
• Lead Sponsor: University of South Florida

Brief 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.

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 Timeline

• Study Start: 2020-01-24
• 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

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

Trial Locations

Locations (1)

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