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. 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 goal of the study is to compare the performance of RSMS and ShuntCheck III in assessing shunt flow with flow-permissive ("valve normal") and restricted-flow ("virtual off") settings. Results from this study may help support the future development of a noninvasive tool to aid neurosurgeons in assessing CSF shunt flow. Participants are not expected to receive a direct medical benefit from taking part in the study.
Existing ventricular cerebrospinal fluid (CSF) shunt.
Region of intact skin overlying an unambiguously identifiable, palpable, chronically indwelling ventricular shunt crossing the clavicle and appropriate in size for application of the study device.
Written informed consent provided by the participant or, when applicable, by a parent, legal guardian, health care agent, or surrogate decision maker according to local regulations.
Presence of more than one distal shunt catheter in the study device measurement region.
Presence of an open wound or edema in the study device measurement region that would interfere with device placement.
Shunt difficult to palpate or shunt depth greater than 5 mm from the skin surface at the measurement location as determined by ultrasound.
Subject-reported or documented history of serious adverse skin reactions to silicone-based adhesives.
Single group
Rhaeos Shunt Monitoring System (RSMS)
DeviceThe Rhaeos Shunt Monitoring System (RSMS) is an investigational, wireless, noninvasive thermal flow detection device that is applied to the skin overlying an implanted cerebrospinal fluid (CSF) shunt. The device uses controlled thermal energy and temperature sensors to detect thermal patterns associated with CSF flow. Measurements are obtained using a tablet application, and device results are encoded to maintain blinding. The device is used for research purposes only and is not used to guide clinical care.
ShuntCheck III
DeviceShuntCheck III is an FDA-cleared, noninvasive thermal flow detection device used as the predicate comparator. The device uses transcutaneous thermal dilution produced by an instant cold pack and a disposable thermosensor array applied over the implanted CSF shunt to detect shunt flow. Measurements are obtained using the manufacturer's software, and results are encoded to maintain blinding. The device is used for comparison with the investigational device and is not used to guide clinical care during the study.
Sensitivity of the Rhaeos Shunt Monitoring System Compared With ShuntCheck III
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 identified as "flow not confirmed."
Rate of Measured Flow in Flow Permissive Shunt Settings of the Rhaeos® Shunt Monitoring System Compared With ShuntCheck III
Rate of Measured Flow in Flow Permissive Shunt Settings 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.
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Rhaeos, Inc.
Lead sponsor
OSF Healthcare System
Collaborator
Johns Hopkins University
Collaborator
SUNY Research Foundation
Collaborator
Northwestern Memorial Hospital
Collaborator
Springfield Clinic
Collaborator
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