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

Launched by RHAEOS, INC. · May 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called FlowSense®, which is designed to check the flow of cerebrospinal fluid (CSF) in patients who already have a shunt implanted for hydrocephalus. Hydrocephalus is a condition where there is too much fluid in the brain, and a shunt helps to drain this fluid. The trial will look at how well the FlowSense® device works by measuring CSF flow in patients during routine check-ups with their neurosurgeon. This study will help researchers understand if the device can provide reliable information without needing more invasive procedures and how it might change the way doctors monitor shunt function.

To be eligible for this trial, participants must be at least 2 years old and already have a ventricular CSF shunt in place. They should also have a specific area of skin where the shunt can be easily felt and be able to provide informed consent, either themselves or through a guardian. The trial is not yet recruiting participants, but those who join can expect a non-invasive assessment during their regular visits, which may help improve future care for patients with similar conditions.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • 1. Existing ventricular cerebrospinal fluid shunt
• • 2. Age ≥ 2 years old
• • 3. 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
• • 4. Capable of providing informed consent or have a legal guardian, health care agent, or surrogate decision-maker able to provide informed consent
• • 5. Standard of care outpatient visit with neurosurgeon assessment of having "no clinical concern for shunt malfunction"
• • Exclusion criteria
• • 1. Subject not scheduled to receive outpatient standard of care imaging (CT, MRI, X-ray shunt series) as part of the clinic visit
• • 2. Presence of more than one distal shunt catheter in the study device measurement region
• • 3. Presence of an interfering open wound or edema in the study device measurement region
• • 4. Subject-reported history of adverse skin reactions to silicone adhesives
• • 5. Participation in the study will interfere with, or be detrimental to, the administration of optimal health care to the subject
• • 6. Subject not available for seven-day follow-up