Study of Shunt Flow Using Wireless Sensor for Hydrocephalus

This study is looking at a new, non-invasive (no needles or surgery) device called the Rhaeos Shunt Monitoring System (RSMS). It's designed to check if your cerebrospinal fluid (CSF) shunt, which drains fluid from your brain if you have hydrocephalus, is working properly. Shunts can sometimes stop working, and it can be hard to tell if there's a problem without complex tests. The RSMS uses thermal sensing to detect fluid flow. We're comparing the RSMS to an existing FDA-cleared device called ShuntCheck III to see how well the new system identifies shunt flow. You may be able to join if you have an existing CSF shunt with a clear, palpable (can be felt) section of the shunt under your skin.

Study design
This is an interventional study with a planned enrollment of 85 participants. It compares the Rhaeos Shunt Monitoring System (RSMS) with ShuntCheck III.
What's involved
The primary endpoints are measured at Day 1 (study visit), suggesting a short participation period.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at Day 1 (study visit).

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NCT07679035

Study of Shunt Flow Under Different Valve Settings Using a Wireless Sensor

Not Yet Recruiting
NAAll AgesInterventionalDiagnostic
Rhaeos, Inc.
~85 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:Rhaeos Shunt Monitoring System (RSMS)ShuntCheck III

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity of the Rhaeos Shunt Monitoring System Compared With ShuntCheck III
Measured over Day 1 (study visit)
+1 more outcome measured
Hydrocephalus
1 sites across 1 states
Illinois1

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  • Sensitivity of the Rhaeos Shunt Monitoring System Compared With ShuntCheck IIIDay 1 (study visit)

    Sensitivity of the investigational Rhaeos Shunt Monitoring System (RSMS) compared with the FDA-cleared predicate device (ShuntCheck III) for identifying non-flowing cerebrospinal fluid shunts during the "virtual off" valve setting. Sensitivity is calculated as the proportion of "virtual off" measurements correctly identified as "flow not confirmed."

  • Specificity of the Rhaeos® Shunt Monitoring System Compared With ShuntCheck IIIDay 1 (study visit)

    Specificity of the investigational Rhaeos Shunt Monitoring System (RSMS) compared with the FDA-cleared predicate device (ShuntCheck III) for identifying flow-permissive cerebrospinal fluid shunts during the prescribed "valve normal" setting. Specificity is calculated as the proportion of flow-permissive measurements correctly identified as "flow confirmed."