An interventional study of wireless thermal anisotropy measurement device in Hydrocephalus, sponsored by Rhaeos, Inc.. Recruiting at 2 sites in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Rhaeos, Inc. · Not applicable, Interventional, and Device feasibility
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
Exclusion Criteria:
Pediatric hydrocephalus patients with an existing ventricular CSF shunt and a history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure will be enrolled.
Device: wireless thermal anisotropy measurement device
Pediatric hydrocephalus patients with an existing ventricular CSF shunt and a shunt revision in the previous 7 days who the investigator judges will likely be discharged within 4 days of the enrollment date will be enrolled.
Device: wireless thermal anisotropy measurement device
Wireless wearable thermal anisotropy measurement device designed for use at home will be provided to study subjects in both study arms
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 (1 = easy to use; 5 = difficult to use)
Time frame: 30 days
Plan to share: No
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Rhaeos, Inc.