Assessment of CSF Shunt Flow in an Outpatient Setting with a Thermal Measurement Device
NCT ID: NCT06753929
Last Updated: 2025-02-10
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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COMPLETED
NA
20 participants
INTERVENTIONAL
2024-12-10
2025-02-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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CSF Shunted Patients
The trial will include two cohorts. The study device will be used to assess CSF flow in Cohort A (prospective). The study device will not be used for Cohort B (retrospective).
wireless wearable thermal anisotropy measurement device
non-invasive device used for assessing CSF shunt flow via thermal anisotropy measurements in a routine outpatient clinic setting
Interventions
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wireless wearable thermal anisotropy measurement device
non-invasive device used for assessing CSF shunt flow via thermal anisotropy measurements in a routine outpatient clinic setting
Eligibility Criteria
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Inclusion Criteria
2. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
3. Subject available for 2 week follow-up
4. Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt that crosses the clavicle; region of skin is appropriate in size for application of the study device (Cohort A only)
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. Participation in the study will interfere with, or be detrimental to, the administration of optimal health care to the subject
ALL
No
Sponsors
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Rhaeos, Inc.
INDUSTRY
Responsible Party
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Locations
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New Neurons Neurosurgical Institute
Cedar Knolls, New Jersey, United States
Countries
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Other Identifiers
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2024-06
Identifier Type: -
Identifier Source: org_study_id
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