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
BASIC_SCIENCE
Masking
NONE
Enrollment
20
Wireless wearable thermal anisotropy measurement device designed for use at home
Rhaeos Inc.
Chicago, Illinois, United States
Adverse 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
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.