Rhaeos, Inc.
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).
Inclusion criteria 1. Existing ventricular cerebrospinal fluid shunt 2. Age ≥ 2 years old 3. Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt that crosses the clavicle; region of skin is appropriate in size for application of the study device 4. Capable of providing informed consent or have a legal guardian, health care agent, or surrogate decision-maker able to provide informed consent 5. Standard of care outpatient visit with neurosurgeon assessment of having "no clinical concern for shunt malfunction" Exclusion criteria 1. Su…
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.
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