Study of a Device to Measure CSF Shunt Flow
This study is looking at a new wireless device that measures how well cerebrospinal fluid (CSF) shunts are working. CSF shunts are tubes placed in the brain to drain extra fluid, which is a condition called hydrocephalus. The device, called a wireless thermal anisotropy measurement device, is worn at home and checks shunt flow during daily activities and sleep. This study wants to see if the device works well and is safe. You might be able to join if you have an existing CSF shunt and are either stable with no recent shunt problems, or if you've had a shunt revision (surgery to fix a shunt) recently. The study plans to enroll 28 people.
- Study design
- This is an interventional study with an unclear status, planning to enroll 28 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would wear a wireless thermal anisotropy measurement device at home to measure CSF shunt flow during daily activities and sleep.
- Compensation
- Not stated in the trial record.
- Follow-up
- Adverse device effects will be measured at 30 days.
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 CSF Shunt Flow During Activities of Daily Living and Sleep With a Thermal Measurement Device
At a glance
Conditions
Where it's being run
2 sites across 2 statesWho to contact
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What this trial measures
- Adverse Device Effects30 days
The co-primary endpoints in this study are the rate of ADEs and SADEs that occur per wear hour.