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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Study of Shunt Flow Under Different Valve Settings Using a Wireless Sensor
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- 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."