Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device

Launched by RHAEOS, INC. · May 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a special device that non-invasively measures how well a cerebrospinal fluid (CSF) shunt is working in patients with hydrocephalus. Hydrocephalus is a condition where excess fluid builds up in the brain, and many patients with this condition experience frequent headaches. The goal of the study is to see how the device can help assess CSF flow during both headache and non-headache periods.

To be eligible for the study, participants must already have a specific type of shunt called a ventriculoperitoneal shunt and have at least 15 headache days each month for the past three months. Participants should be between 6 and 80 years old and must be able to communicate in English. During the study, participants will use the device for 30 days, with both remote and in-person follow-ups to check on their progress. It’s important to note that those with certain skin conditions or other specific medical issues may not qualify for the study. Overall, this trial aims to help improve understanding of CSF shunt performance and headache management in patients with hydrocephalus.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Existing ventriculoperitoneal CSF shunt
• • 2. Subject experiencing ongoing headaches including at least 15 headache days per month for the past 3 months
• • 3. Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
• • 4. Available for remote and in-person follow-up during the 30-day measurement period
• • 5. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
• • 6. Subject or caregiver is able to clearly communicate and document information and shunt symptoms in English
• • 7. Subject is at least 6 years old but not more than 80 years old
• Exclusion Criteria:
• • 1. Presence of more than one distal shunt catheter in the study device measurement region
• • 2. Shunt is not palpable due to depth or depth of shunt where the device will be placed is greater than 4 mm per ultrasound evaluation
• • 3. Presence of an interfering open wound or edema in the study device measurement region
• • 4. Subject-reported history of serious adverse skin reactions to silicone-based adhesives
• • 5. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
• • 6. Investigator judges that the subject is unlikely to successfully take reliable measurements at home
• • 7. Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance
• • 8. Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject
• • 9. Prior enrollment in this study
• • 10. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study