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).
Existing ventricular cerebrospinal fluid shunt
Age ≥ 2 years old
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
Capable of providing informed consent or have a legal guardian, health care agent, or surrogate decision-maker able to provide informed consent
Subject not scheduled to receive outpatient standard of care imaging (CT, MRI, X-ray shunt series) as part of the clinic visit
Presence of more than one distal shunt catheter in the study device measurement region
Presence of an interfering open wound or edema in the study device measurement region
Subject-reported history of adverse skin reactions to silicone adhesives
Single group
Thermal Anisotropy Measurement Device
DeviceThe 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.
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.
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