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.

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NCT07050628

Assessment of CSF Shunt Flow During Activities of Daily Living and Sleep With a Thermal Measurement Device

Recruiting
NAAges 2+InterventionalDevice feasibility
Rhaeos, Inc.
~28 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:wireless thermal anisotropy measurement device

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Device Effects
Measured over 30 days
Hydrocephalus
2 sites across 2 states
Illinois1
Virginia1

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  • Adverse Device Effects30 days

    The co-primary endpoints in this study are the rate of ADEs and SADEs that occur per wear hour.