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

ConditionHydrocephalus
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorRhaeos, Inc.

About this trial

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 goal of the study is to compare the ability of RSMS and ShuntCheck III to correctly identify shunts 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Rhaeos Shunt Monitoring System (RSMS)

    Device

    The 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

    Device

    ShuntCheck 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.

Treatment groups

85 Participants
are divided into 1 treatment group
Group A: Participants Undergoing Paired CSF Shunt Flow AssessmentOther 2 interventions

Trial outcomes

Primary outcomes

1

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 correctly identified as "flow not confirmed."

Time frame
Day 1 (study visit)
2

Specificity of the Rhaeos® Shunt Monitoring System Compared With ShuntCheck III

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."

Time frame
Day 1 (study visit)

Secondary outcomes

Other outcomes

Sponsors and contacts

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Rhaeos, Inc.

Lead sponsor

Springfield Clinic

Collaborator

OSF Healthcare System

Collaborator

Johns Hopkins University

Collaborator

SUNY Research Foundation

Collaborator

Northwestern Memorial Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: