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NCT07815314

A Prospective Study Comparing CSF Shunt Flow Between "Virtual Off" and "Flow Permissive" Shunt Valve Settings Using a Wireless, Noninvasive Shunt Flow Sensor

Sponsor: Rhaeos, Inc.

View on ClinicalTrials.gov

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. 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.

Official title: A Prospective Study Comparing CSF Shunt Flow Between "Virtual Off" and "Flow-Permissive" Shunt Valve Settings Using a Wireless, Noninvasive Shunt Flow Sensor

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-09-08

Completion Date

2027-01-31

Last Updated

2026-09-11

Healthy Volunteers

Conditions

Hydrocephalus

Interventions

DEVICE

Rhaeos Shunt Monitoring System (RSMS)

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.

DEVICE

ShuntCheck III

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.

Inclusion Criteria: * 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. For participants with planned "virtual off" measurements: -Existing ventricular CSF shunt with a programmable valve that has an available manufacturer-reported "virtual off" setting and can be programmed noninvasively. For participants whose valve will be adjusted to the "virtual off" setting during the study: -Subject-reported or documented history of successful shunt valve adjustment(s). Exclusion Criteria: * 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. * New or worsening symptoms suggestive of shunt malfunction within the previous 7 days. * Use of the study device would interfere with standard patient care, emergency surgery cannot be delayed, or study participation would interfere with optimal medical care. * Participation in another investigational procedural, pharmaceutical, or device study that may affect data collected in this study. * Previous participation in a Rhaeos clinical study using the current-generation RH05-B1 study device. For participants with planned "valve normal" measurements only: -Investigator judges the participant is likely to be shunt independent (e.g., does not require a functional shunt for management of hydrocephalus). This format follows ClinicalTrials.gov conventions by separating general criteria from those that apply only to specific participant subgroups.

Locations (1)

Rhaeos, Inc

Chicago, Illinois, United States