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Formative Usability Assessment of Wireless Thermal Anisotropy Devices

Recruitingn/aAges 5 Years - 80 YearsAllRhaeos, Inc.
NCT06040697 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Existing ventricular CSF shunt with a region of intact skin overlying the shunt catheter appropriate in size for application of the study device 2. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes) 3. Subject or caregiver can clearly communicate and document information in English 4. Verbal assent by minors 12 years of age and older who can understand the study and communicate their decision 5. Subject is at least 5 years old but not more than 80 years old Exclusion Criteria: 1. Presence of an interfering open wound in the device application region 2. Subject-reported history of adverse skin reactions to adhesives
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What it tests

  • Thermal Anisotropy
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Where

1 site
Rhaeos, Inc.
Chicago, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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