Evaluating a Device for Measuring Shunt Flow in Hydrocephalus

This study is testing a new device called the Thermal Anisotropy Measurement Device. This device is a non-invasive sensor that sits on your skin over an existing cerebrospinal fluid (CSF) shunt. It uses heat and temperature sensors to check how well the shunt is flowing. The study wants to see how well this device works to measure shunt flow over time. You might be able to join if you are between 5 and 80 years old and have an existing CSF shunt. The study will measure your skin temperature and acceleration for up to 90 days to see how the device performs. The current status of this study is unclear, and it plans to enroll 130 people.

Study design
This interventional study plans to enroll 130 participants. It is evaluating a non-invasive device for measuring shunt flow.
What's involved
You would wear the Thermal Anisotropy Measurement Device on your skin over an existing CSF shunt. The device will collect data over time.
Compensation
Not stated in the trial record.
Follow-up
Your skin temperature and acceleration will be measured for up to 90 days.

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NCT06086561

Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device

Recruiting
NAAges 5–80InterventionalBasic science
Rhaeos, Inc.
~130 participants
Updated 2025-05-15 on ClinicalTrials.gov
What's tested:Thermal Anisotropy Measurement Device

At a glance

Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Skin Temperature
Measured over up to 90 days
+1 more outcome measured
Hydrocephalus
4 sites across 2 states
Illinois3
Florida1

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  • Skin Temperatureup to 90 days

    Exploratory assessment of thermal skin measurements taken with the study device

  • Accelerationup to 90 days

    Exploratory assessment of accelerometer measurements taken with the study device