Status:
RECRUITING
Formative Usability Assessment of Wireless Thermal Anisotropy Devices
Lead Sponsor:
Rhaeos, Inc.
Conditions:
Hydrocephalus
Eligibility:
All Genders
5-80 years
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.
Eligibility Criteria
Inclusion
- 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
- Presence of an interfering open wound in the device application region
- Subject-reported history of adverse skin reactions to adhesives
Key Trial Info
Start Date :
September 29 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT06040697
Start Date
September 29 2023
End Date
December 1 2025
Last Update
May 15 2025
Active Locations (1)
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1
Rhaeos, Inc.
Chicago, Illinois, United States, 60654