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

A vizsgálat adatai

Ki végzi

Rhaeos, Inc.

Azonosító

NCT07679035

A regiszteradat frissítve

2026. július 1.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

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

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.

Bevonási feltételek: 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).

Kizáró feltételek: 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; Previous participation in a Rhaeos clinical study using the current-generation RH05-B1 study device; Subject-reported or documented history of serious adverse skin reactions to silicone-based adhesives; 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; Participation in another investigational procedural, pharmaceutical, or device study that may affect data collected in this study; 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.

ClinicalTrials.gov NCT07679035