See if a wireless thermal device can measure CSF shunt flow during daily activities and sleep

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study tests a wireless thermal anisotropy measurement device designed to non-invasively monitor cerebrospinal fluid (CSF) shunt flow. Participants with existing ventricular shunts will wear the device while going about daily activities and sleeping, with measurements taken over multiple sessions. Cohort A includes participants with stable shunt history and no recent revisions, while Cohort B includes those with a recent shunt revision and expected discharge within a few days. Safety, feasibility, and data quality will be assessed to determine if the device can reliably reflect shunt flow in real-life conditions.

Why it matters

Who can join: the full rules

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

Where it's running

• Rhaeos Inc.
  Chicago, Illinois, United States Recruiting
• Virginia Commonwealth University Medical Center
  Richmond, Virginia, United States Recruiting

Study contacts

• Study coordinator: Richard C Webb, PhD
• Email: cwebb@rhaeos.com
• Phone: 855-814-3569

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.