Assessment of CSF Shunt Flow With Thermal Measurements A
NCT ID: NCT05015751
Last Updated: 2024-12-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
44 participants
OBSERVATIONAL
2021-08-25
2022-07-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Hydrocephalus Patients
Hydrocephalus patients with an existing ventriculoperitoneal shunt and symptoms of a shunt malfunction.
Thermal Anisotropy Measurement Device
A wireless device for non-invasively assessing CSF shunt flow.
Interventions
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Thermal Anisotropy Measurement Device
A wireless device for non-invasively assessing CSF shunt flow.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least one symptom of shunt malfunction as determined by the investigator, including seizure, fever, headache, vision problems, dizziness, disorientation, confusion, vomiting, lethargy, irritability, difficulty waking or staying awake, swelling along shunt tract, enlargement of head, loss of balance, gait disturbance, and loss of sensory or motor function
* Suspicion of shunt obstruction warrants the performance of a test for this condition in the investigator's judgement
* Region of intact skin overlying an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
* Available for follow-up for up to fourteen days
* Signed informed consent by patient or a parent, legal guardian, health care agent, or legally authorized representative.
* Verbal assent by minors four years of age and older who are able to understand the study and communicate their decision
Exclusion Criteria
* Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed
* Presence of an interfering open wound or edema over any portion of the shunt
* Patient-reported history of adverse skin reactions to adhesives
* Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
* Participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject
* Prior enrollment in this study (multiple enrollments of the same patient are disallowed)
* Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
ALL
No
Sponsors
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Rhaeos, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sandi Lam
Role: PRINCIPAL_INVESTIGATOR
Ann & Robert H Lurie Children's Hospital of Chicago
Locations
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UCSF Benioff Children's Hospital - Oakland
Oakland, California, United States
UCSF Benioff Children's Hospital
San Francisco, California, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Countries
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References
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Limbrick DD Jr, Skoch J, Auguste K, Grant GA, Lam SK, Tate MC, Langer DJ, Roland JL, Alden TD, Charbel FT, Lober RM, Patten K, Kennedy E, Farless C, Himsworth S, Fasbender R, Lovell-Ewen L, Morales DM, Correia CF, Burton A, Koschnitzky JE, Webb RC, Zysk AM. A Multicenter Study of Noninvasive Wireless Assessment of Cerebrospinal Fluid Shunt Function in Hydrocephalus Patients. Neurosurgery. 2025 Jun 16. doi: 10.1227/neu.0000000000003569. Online ahead of print.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2020-01
Identifier Type: -
Identifier Source: org_study_id