This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow over multiple measurements performed by a study subject during activities of daily living and sleep
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
28
Wireless wearable thermal anisotropy measurement device designed for use at home will be provided to study subjects in both study arms
Rhaeos Inc.
Chicago, Illinois, United States
RECRUITINGVirginia Commonwealth University Medical Center
Richmond, Virginia, United States
RECRUITINGAdverse Device Effects
The co-primary endpoints in this study are the rate of ADEs and SADEs that occur per wear hour.
Time frame: 30 days
ADEs and SADEs per wear period
rate of ADEs and SADEs per wear period
Time frame: 30 days
ADEs and SADEs per subject
rate of ADEs and SADEs per subject;
Time frame: 30 days
ADEs and SADEs that preclude the continued use of the study device
rate of ADEs and SADEs that preclude the continued use of the study device
Time frame: 30 days
Device deficiencies resulting in incomplete monitoring data
percent of device deficiencies resulting in incomplete monitoring data
Time frame: 30 days
Local skin reactions per wear session;
number of local skin reactions per wear session;
Time frame: 30 days
Usability score
usability score based on post-study survey (1 = easy to use; 5 = difficult to use)
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.