Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in Asymptomatic Patients

Starting soon · Not applicable

Conditions studied: Hydrocephalus

In brief

This study evaluates the performance of the study device, FlowSense®, a sensor for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Subjects with an existing implanted ventricular CSF shunt will be evaluated with the study device in an outpatient setting to determine the negative predictive value (NPV; Part 1, blinded) and explore changes in surveillance imaging, health resource utilization, and visit duration during routine follow-up visits (Part 2, unblinded).

Key facts

Study ID

NCT06410885

Run by

Rhaeos, Inc.

People needed

60

Starts

2025-06-01

Expected to finish

2026-05-01

Last updated by the study team

2025-05-15

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Existing ventricular cerebrospinal fluid shunt
• Age ≥ 2 years old
• Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt that crosses the clavicle; region of skin is appropriate in size for application of the study device
• Capable of providing informed consent or have a legal guardian, health care agent, or surrogate decision-maker able to provide informed consent
• Standard of care outpatient visit with neurosurgeon assessment of having "no clinical concern for shunt malfunction"

You may not qualify if…

• Subject not scheduled to receive outpatient standard of care imaging (CT, MRI, X-ray shunt series) as part of the clinic visit
• Presence of more than one distal shunt catheter in the study device measurement region
• Presence of an interfering open wound or edema in the study device measurement region
• Subject-reported history of adverse skin reactions to silicone adhesives
• Participation in the study will interfere with, or be detrimental to, the administration of optimal health care to the subject
• Subject not available for seven-day follow-up

Where it is running

• UCSF Benioff Children's Hospital — San Francisco, California, United States

Full record on ClinicalTrials.gov

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