Assessment of CSF Shunt Flow During Activities of Daily Living and Sleep With a Thermal Measurement Device

Launched by RHAEOS, INC. · Jun 25, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new device that can measure how well a cerebrospinal fluid (CSF) shunt is working without needing surgery or other invasive methods. A CSF shunt is a small tube placed in the brain to help drain extra fluid, which is important for people with hydrocephalus—a condition where fluid builds up inside the brain. This device uses temperature measurements to check the flow of fluid through the shunt during everyday activities and sleep.

The study is looking for participants between the ages of 5 and 21 who already have a ventricular CSF shunt. People can join if they either have a stable shunt that hasn't needed fixing in the last two years and aren't showing symptoms of problems, or if they recently had shunt surgery and are expected to leave the hospital soon. Participants will need to have a shunt that can be easily felt under the skin in a specific area near the collarbone, where the device can be placed. Those who take part will be asked to use the device multiple times while going about their daily routines and during sleep to help researchers understand how well the device works in real-life settings. The study has not started recruiting yet, and anyone interested should speak with their healthcare provider to see if this trial is a good fit.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Existing ventricular CSF shunt
• • 2. (Cohort A) A history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure
• • 3. (Cohort B) A shunt revision in the previous 7 days and the investigator judges that the patient will likely be discharged within 4 days of the enrollment date
• • 4. 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
• • 5. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
• • 6. Subject is at least 5 years old but \< 22 years old
• Exclusion Criteria:
• • 1. Shunt is not palpable or depth of shunt where the device will be placed is greater than 4 mm per ultrasound evaluation
• • 2. Presence of an interfering open wound or edema in the study device measurement region
• • 3. Subject-reported history of serious adverse skin reactions to silicone-based adhesives
• • 4. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
• • 5. Investigator judges that the subject is unlikely to successfully take reliable measurements at home
• • 6. Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance
• • 7. 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
• • 8. Prior enrollment in this study
• • 9. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study