Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus

Hydrocephalus, Normal Pressure Clinical Trial

Official title:

Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04011566
• Other study ID #: Pro00040697
• Status: Recruiting
• Start date: June 11, 2019
• Est. completion date: January 2025

Study information

• Verified date: September 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

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	Specificity of ShuntCheck test		15 minutes
Primary	Negative Predictive Value of ShuntCheck test		15 minutes
Secondary	Specificity of performing ShuntCheck test twice		60 minutes
Secondary	Negative Predictive Value of performing ShuntCheck test twice		60 minutes