This study evaluates the performance of a thermal anisotropy measurement device for non-invasively assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction who require shunt revision surgery will be evaluated with the study device to assess flow in CSF shunts as confirmed by surgical outcomes at 7 days. If successful, this study will show that the study device accurately distinguishes between functioning (flowing) and non-functioning (non-flowing) shunts.
Existing ventriculoperitoneal CSF shunt on which the subject is dependent
At least one symptom of shunt malfunction as determined by the investigator, such as but not limited to seizure, fever, headache, vision problems, dizziness, disorientation, confusion, vomiting, lethargy, irritability, difficulty waking or staying awake, swelling along shunt tract, enlargement of head, loss of balance, gait disturbance, and loss of sensory or motor function
Exhibit shunt malfunction symptom(s) requiring surgical shunt revision per standard of care assessment without use of device data
Region of intact skin overlying an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
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 area
Subject-reported history of adverse skin reactions to adhesives
Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable