Hydrocephalus
Conditions
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.
Interventions
DEVICEThermal Anisotropy
Usability assessment observation.
Sponsors
Rhaeos, Inc.
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
5 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exploratory device usability feedback | 2 hours | Identification of usability risks \[unscored\] |
Countries
United States
Contacts
Primary ContactAnna Somera
Outcome results
None listed