NCT02067364

CRT ShuntCheck "Fit & Function" Study

CRT ShuntCheck "Fit & Function" Exploratory Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: NeuroDx Development · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

Summary

An exploratory "Fit \& Function" study of Continuous Real Time (CRT) ShuntCheck, a non-invasive method for monitoring changes in cerebrospinal fluid (CSF) shunt flow in hydrocephalus patients. The device will be tested on 10 pediatric patients (at Johns Hopkins Hospital) and 10 adult patients (at LifeBridge Health) and results will be used to optimize device design.

Detailed description

An exploratory "Fit \& Function" study of Continuous Real Time (CRT) ShuntCheck, a non-invasive method for monitoring changes in CSF shunt flow in hydrocephalus patients. This study will gather information to refine the design of the CRT ShuntCheck sensor. Our Aim I product work will yield a clinic-ready prototype which adheres well to human skin, conforms to the curve surface of the clavicle and provides a safe level of skin cooling over an extended period of time. Many of the clinical uses of CRT will involve patient movement - standing up to investigate suspected overdrainage, or the simple fidgeting of children undergoing monitoring. The Aim II Fit and Function testing will most importantly identify movement-related product performance issues. If we can identify the causes of "signal noise", we can modify our sensor design to make it less susceptible to "motion artifacts". Additionally testing will identify age/size specific issues - is the sensor small enough for use on younger children, does the looser skin of older adults generate move motion artifacts in the signal. These studies will include 10 pediatric and 10 adult asymptomatic patients who are willing to undergo CRT ShuntCheck testing over a one hour period. Test results will not be used to guide patient care and testing will not interfere with or delay any other patient testing or care.

Conditions

• Hydrocephalus

Interventions

Type	Name	Description
DEVICE	Fit & Function test

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-07-01
• Completion: 2015-08-01
• First posted: 2014-02-20
• Last updated: 2015-06-23

Locations

2 sites across 1 country: United States