Assessment of Flow in Cerebrospinal Fluid Shunts With a Second Generation Wireless Thermal Anisotropy Measurement Device

Launched by RHAEOS, INC. · May 7, 2024

Keywords

ClinConnect Summary

This clinical trial is examining a new device that can help doctors check how well cerebrospinal fluid (CSF) shunts are working without needing to do surgery. The study focuses on patients who already have a CSF shunt and are showing signs that it might not be functioning properly, such as headaches, dizziness, or vision problems. If you or your loved one has an existing ventriculoperitoneal shunt and is experiencing these symptoms, you might be eligible to participate. To join, participants need to be available for follow-up for up to seven days and must give consent, either personally or through a guardian.

During the trial, the new device will be used to assess the flow of CSF in the shunt. The goal is to determine if this device can accurately tell whether the shunt is working or if it needs to be repaired, based on what the doctors find during surgery a week later. The study is not yet recruiting participants, but it aims to improve how doctors can monitor shunt function in the future, making it easier for patients to get the care they need.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Existing ventriculoperitoneal CSF shunt on which the subject is dependent
• • 2. At least one symptom of shunt malfunction as determined by the investigator, such as but not limited to seizure, fever, headache, vision problems, dizziness, disorientation, confusion, vomiting, lethargy, irritability, difficulty waking or staying awake, swelling along shunt tract, enlargement of head, loss of balance, gait disturbance, and loss of sensory or motor function
• • 3. Exhibit shunt malfunction symptom(s) requiring surgical shunt revision per standard of care assessment without use of device data
• • 4. Region of intact skin overlying an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
• • 5. Available for follow-up for up to seven days
• • 6. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol)
• Exclusion Criteria:
• • 1. Presence of more than one distal shunt catheter in the study device measurement region
• • 2. Presence of an interfering open wound or edema in the study device measurement area
• • 3. Subject-reported history of adverse skin reactions to adhesives
• • 4. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
• • 5. Participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject
• • 6. Previous participation in a Rhaeos clinical study in which FlowSense device measurement data were acquired
• • 7. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study