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.

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NCT05546996

EVD Drainage Data and Intracranial Pressure (ICP) Measurements

Recruiting
NAAges 1–21InterventionalPrevention
Baylor College of Medicine
~24 participants
Updated 2026-03-25 on ClinicalTrials.gov
What's tested:FlowSense

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Exploratory outcome
Measured over 1 year
Hydrocephalus
1 sites across 1 states
Texas1
  • Samuel McClugage, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine

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Eligibility criteria

Inclusion

Patients with one or more existing external ventricular drains (EVDs).

Exclusion

Patients with no external ventricular drains (EVDs).
  • 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