An interventional study of Thermal Anisotropy Measurement Device in Hydrocephalus, sponsored by Rhaeos, Inc.. Not yet recruiting at 1 site in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by Rhaeos, Inc. · Not applicable, Interventional, and Diagnostic
This study evaluates the performance of the study device, FlowSense®, a sensor for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Subjects with an existing implanted ventricular CSF shunt will be evaluated with the study device in an outpatient setting to determine the negative predictive value (NPV; Part 1, blinded) and explore changes in surveillance imaging, health resource utilization, and visit duration during routine follow-up visits (Part 2, unblinded).
210 studies on the registry are indexed under Hydrocephalus; 51 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 105 interventional studies indexed under Hydrocephalus.
Browse Hydrocephalus studies →Rhaeos, Inc. is the lead sponsor of 15 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria
Device: Thermal Anisotropy Measurement Device
Device: Thermal Anisotropy Measurement Device
The study device is a non-invasive sensor that is placed on the study subject's skin overlying an existing implanted CSF shunt. It uses an integrated thermal actuator and temperature sensors to assess shunt flow.
Study device negative predictive value (NPV)
The study device will produce either "flow confirmed" or "flow not confirmed" data in a blinded fashion. Ground truth will be established based on 7-day follow-up an intraoperative observations for any surgery performed per the standard of care.
Time frame: Up to 7 days
Study device sensitivity, specificity, diagnostic accuracy, and positive predictive value (PPV)
The study device will produce either "flow confirmed" or "flow not confirmed" data in a blinded fashion. Ground truth will be established based on 7-day follow-up an intraoperative observations for any surgery performed per the standard of care.
Time frame: Up to 7 days
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Rhaeos, Inc.