FlowSense for Hydrocephalus Patients with EVDs
This study is testing a new device called FlowSense for children and young adults (ages 1 to 21) who have hydrocephalus. Hydrocephalus is a condition where there is too much fluid in the brain. FlowSense is a soft, wireless sensor, like a bandage, that attaches to the skin over an existing external ventricular drain (EVD). An EVD is a tube that helps drain fluid from the brain. The study aims to see how well FlowSense can measure the amount of fluid draining from the EVD. This is an exploratory study, meaning it's looking for new information, and will follow participants for one year. The study is currently unclear on its status and plans to enroll 24 participants.
- Study design
- This interventional study plans to enroll 24 participants aged 1 to 21 years. It is designed to test a new device, FlowSense.
- What's involved
- Patients will have one or more existing external ventricular drains (EVDs). For some patients, there will also need to be a shaved skin area of at least 3 cm x 3 cm over the EVD tubing.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for one year to collect exploratory outcome data.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
EVD Drainage Data and Intracranial Pressure (ICP) Measurements
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Samuel McClugage, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Exploratory outcome1 year
Number of participants with accurate cerebrospinal flow rate measurements (measured through the FlowSense device), EVD drainage, intracranial pressure measurements. This will be measured using a video camera. We will see the changes in flow for every 20 minutes in the recording. However, this project is not intended to be statistically powered