Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device
This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Patients with an existing implanted shunt will wear the device to acquire longitudinal data.
• At least one existing ventricular CSF shunt (functional or non-functional, including virtual off and ligated, orphaned, abandoned, tied-off, or fractured distal catheters)
• Region(s) of intact skin overlying at least one unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
• Available for remote and in-person follow-up during the 30-day measurement period (for subjects using the study device at home)
• Subject is expected to remain in an inpatient setting for sufficient time to complete all required study device measurements (for subjects using the device in an inpatient hospital setting)
• Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
• Subject or caregiver is able to clearly communicate and document information and shunt symptoms in English
• Verbal assent by minors 12 years of age and older who are able to understand the study and communicate their decision
• Patient is at least 5 years old but not more than 80 years old