Assessment of Flow in Cerebrospinal Fluid Shunts With a Second Generation Wireless Thermal Anisotropy Measurement Device
NCT ID: NCT06409286
Last Updated: 2025-05-15
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
17 participants
OBSERVATIONAL
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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COHORT
PROSPECTIVE
Study Groups
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Shunted patients undergoing surgery
Patients with an existing implanted ventriculoperitoneal shunt who are experiencing shunt malfunction symptoms and require shunt revision surgery per standard of care shunt evaluation
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
2. At least one symptom of shunt malfunction as determined by the investigator, such as but not limited to 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
3. Exhibit shunt malfunction symptom(s) requiring surgical shunt revision per standard of care assessment without use of device data
4. 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
5. Available for follow-up for up to seven days
6. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol)
Exclusion Criteria
2. Presence of an interfering open wound or edema in the study device measurement area
3. Subject-reported history of adverse skin reactions to adhesives
4. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
5. Participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject
6. Previous participation in a Rhaeos clinical study in which FlowSense device measurement data were acquired
7. 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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Locations
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Washington University in St. Louis
St Louis, Missouri, 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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2024-01
Identifier Type: -
Identifier Source: org_study_id
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