Formative Usability Assessment of Wireless Thermal Anisotropy Devices
Study Details
Study Description
Brief Summary
Measurements of shunt flow will be performed non-invasively. This study will generate usability data via observed tasks and comprehension questions to enable future device design improvements.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Usability Assessment Cohort No interventions administered. Device usability assessment only. |
Device: Thermal Anisotropy
Usability assessment observation.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Exploratory device usability feedback [2 hours]
Identification of usability risks [unscored]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Existing ventricular CSF shunt with a region of intact skin overlying the shunt catheter appropriate in size for application of the study device
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Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
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Subject or caregiver can clearly communicate and document information in English
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Verbal assent by minors 12 years of age and older who can understand the study and communicate their decision
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Subject is at least 5 years old but not more than 80 years old
Exclusion Criteria:
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Presence of an interfering open wound in the device application region
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Subject-reported history of adverse skin reactions to adhesives
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Rhaeos, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-02