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

Study Summary

Hydrocephalus is commonly treated with a cerebrospinal fluid (CSF) shunt, a device that drains excess fluid from the brain. However, shunts can stop working over time, and determining whether fluid is flowing through a shunt can be difficult. Current diagnostic methods may require imaging studies or invasive procedures, which can be time-consuming, costly, or uncomfortable for patients. The purpose of this study is to evaluate the performance of the Rhaeos Shunt Monitoring System (RSMS), an investigational wireless, noninvasive device designed to detect flow in implanted CSF shunts. The study will compare RSMS directly with ShuntCheck III, an FDA-cleared noninvasive device that is also used to assess CSF shunt flow. Both devices are placed on the skin over the shunt and use thermal sensing technology to evaluate whether fluid is flowing through the shunt. Approximately 85 pediatric and adult participants with an existing ventricular CSF shunt will be enrolled. Participants must have a functioning shunt and no recent symptoms suggesting shunt malfunction. Some participants with programmable shunt valves will have their valve temporarily adjusted to a manufacturer-provided "virtual off" setting, which is intended to substantially restrict shunt flow. These participants may also undergo measurements at their normal valve setting. Other participants will only undergo measurements at their normal valve setting. During the study visit, participants will undergo shunt flow assessments with both RSMS and ShuntCheck III. The order in which the devices are used will be randomized. Device measurements are collected while participants are seated upright, and participants and their treating clinicians will remain blinded to the measurement results. The study devices will not be used to make treatment decisions, and participation will not alter standard medical care. Adverse events associated with device use or valve adjustments will be monitored and recorded. The primary goa

Primary Outcome

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."

Interventions

• DEVICE Rhaeos Shunt Monitoring System (RSMS)
• DEVICE ShuntCheck III