Formative Usability Assessment of Wireless Thermal Anisotropy Devices Measuring Flow in Cerebrospinal Fluid Shunts
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 80
Healthy Volunteers: t
View:
• 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
Locations
United States
Illinois
Rhaeos, Inc.
RECRUITING
Chicago
Contact Information
Primary
Anna Somera
info@rhaeos.com
855-814-3569
Time Frame
Start Date: 2023-09-29
Estimated Completion Date: 2025-12
Participants
Target number of participants: 145
Treatments
Usability Assessment Cohort
No interventions administered. Device usability assessment only.
Related Therapeutic Areas
Sponsors
Leads: Rhaeos, Inc.