Observational Study of a Wireless Device for CSF Shunt Flow
This study is looking at a new wireless device called the Thermal Anisotropy Measurement Device. This device helps doctors check the flow in cerebrospinal fluid (CSF) shunts without needing surgery. You might be able to join if you have hydrocephalus (a buildup of fluid in the brain) and an existing CSF shunt that you rely on. You also need to be experiencing symptoms that suggest your shunt might not be working correctly, such as headaches or vision problems, and be scheduled for shunt revision surgery. The goal is to see if this device can accurately tell the difference between shunts that are working and those that are not, which will be confirmed by the results of your surgery within 7 days. The study is currently recruiting about 17 participants.
- Study design
- This is an observational study, meaning researchers will be watching and collecting information without giving new treatments. It aims to enroll about 17 participants.
- What's involved
- You will be evaluated with the study device before your scheduled shunt revision surgery. Your surgical outcomes will be used to confirm the device's accuracy within 7 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess the device's accuracy based on surgical outcomes up to 7 days after evaluation.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Assessment of Flow in Cerebrospinal Fluid Shunts With a Second Generation Wireless Thermal Anisotropy Measurement Device
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Flowsense SensitivityUpto 7 days
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).