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
Pediatric and adult shunt-dependent hydrocephalus patients with an existing ventriculoperitoneal (VP) shunt who are experiencing shunt malfunction symptoms and require shunt revision surgery per standard of care shunt evaluation without use of the study device data will be enrolled in this study.
Cohort
Prospective
Thermal Anisotropy Measurement Device
DeviceA wireless device for non-invasively assessing CSF shunt flow
Flowsense Sensitivity
The study device will yield an output of either "flow confirmed" or "flow not confirmed." Based on this assessment and the standard-of-care clinical treatment, each subject will fall into one of the following categories: True Positive (TP): Device outputs "flow not confirmed" AND a shunt revision surgery with confirmed shunt failure is performed False Positive (FP): Device outputs "flow not confirmed" AND either no shunt revision surgery is performed for 7 days or a shunt revision surgery without a confirmed shunt failure is performed True Negative (TN): Device outputs "flow confirmed" AND either no shunt revision surgery is performed for 7 days or a shunt revision surgery without a confirmed shunt failure is performed False Negative (FN): Device outputs "flow confirmed" AND a shunt revision surgery with confirmed shunt failure is performed Study device sensitivity will be calculated as TP / (TP + FN).
Study device specificity, diagnostic accuracy, positive predictive value (PPV), negative predictive value (NPV), and diagnostic performance
These secondary endpoints do not have associated success criteria. The study is not powered to achieve statistical significance for these endpoints.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
