RecruitingNCT06040697
Formative Usability Assessment of Wireless Thermal Anisotropy Devices
Formative Usability Assessment of Wireless Thermal Anisotropy Devices Measuring Flow in Cerebrospinal Fluid Shunts
Sponsor
Rhaeos, Inc.
Enrollment
145 participants
Start Date
Sep 29, 2023
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 5 YearsMax Age: 80 Years
Inclusion Criteria5
- Existing ventricular CSF shunt with a region of intact skin overlying the shunt catheter appropriate in size for application of the study device
- Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
- Subject or caregiver can clearly communicate and document information in English
- Verbal assent by minors 12 years of age and older who can understand the study and communicate their decision
- Subject is at least 5 years old but not more than 80 years old
Exclusion Criteria2
- Presence of an interfering open wound in the device application region
- Subject-reported history of adverse skin reactions to adhesives
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Interventions
DEVICEThermal Anisotropy
Usability assessment observation.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06040697
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