Assessment of CSF Shunt Flow During Activities of Daily Living and Sleep With a Thermal Measurement Device
Long-Term Tracking of Fluid Dynamics in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device During Activities of Daily Living Including Sleep
2 other identifiers
interventional
28
1 country
2
Brief Summary
This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow over multiple measurements performed by a study subject during activities of daily living and sleep
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2025
CompletedFirst Posted
Study publicly available on registry
July 3, 2025
CompletedStudy Start
First participant enrolled
November 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
July 24, 2026
July 1, 2026
10 months
June 25, 2025
July 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse Device Effects
The co-primary endpoints in this study are the rate of ADEs and SADEs that occur per wear hour.
30 days
Secondary Outcomes (6)
ADEs and SADEs per wear period
30 days
ADEs and SADEs per subject
30 days
ADEs and SADEs that preclude the continued use of the study device
30 days
Device deficiencies resulting in incomplete monitoring data
30 days
Local skin reactions per wear session;
30 days
- +1 more secondary outcomes
Study Arms (2)
No Recent Revision
EXPERIMENTALPediatric hydrocephalus patients with an existing ventricular CSF shunt and a history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure will be enrolled.
Recent Revision
EXPERIMENTALPediatric hydrocephalus patients with an existing ventricular CSF shunt and a shunt revision in the previous 7 days who the investigator judges will likely be discharged within 4 days of the enrollment date will be enrolled.
Interventions
Wireless wearable thermal anisotropy measurement device designed for use at home will be provided to study subjects in both study arms
Eligibility Criteria
You may qualify if:
- Existing ventricular CSF shunt
- (Cohort A) A history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure
- (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
- 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
- Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
- Subject is at least 5 years old but \< 22 years old
You may not qualify if:
- Shunt is not palpable or depth of shunt where the device will be placed is greater than 4 mm per ultrasound evaluation
- Presence of an interfering open wound or edema in the study device measurement region
- Subject-reported history of serious adverse skin reactions to silicone-based adhesives
- Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
- Investigator judges that the subject is unlikely to successfully take reliable measurements at home
- Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance
- 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
- Prior enrollment in this study
- Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Rhaeos Inc.
Chicago, Illinois, 60642, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2025
First Posted
July 3, 2025
Study Start
November 10, 2025
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
June 30, 2027
Last Updated
July 24, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share