Assessment of CSF Shunt Flow During Activities of Daily Living and Sleep With a Thermal Measurement Device
NCT ID: NCT07050628
Last Updated: 2025-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2025-07-31
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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No Recent Revision
Pediatric 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.
wireless thermal anisotropy measurement device
Wireless wearable thermal anisotropy measurement device designed for use at home
Recent Revision
Pediatric 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.
wireless thermal anisotropy measurement device
Wireless wearable thermal anisotropy measurement device designed for use at home
Interventions
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wireless thermal anisotropy measurement device
Wireless wearable thermal anisotropy measurement device designed for use at home
Eligibility Criteria
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Inclusion Criteria
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
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
5 Years
21 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Rhaeos, Inc.
INDUSTRY
Responsible Party
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Locations
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Rhaeos Inc.
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-03
Identifier Type: -
Identifier Source: org_study_id
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