Formative Usability Assessment of Wireless Thermal Anisotropy Devices
Recruiting
- Conditions
- Hydrocephalus
- Interventions
- Device: Thermal Anisotropy
- Registration Number
- NCT06040697
- Lead Sponsor
- Rhaeos, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 145
Inclusion Criteria
- 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 Criteria
- Presence of an interfering open wound in the device application region
- Subject-reported history of adverse skin reactions to adhesives
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Usability Assessment Cohort Thermal Anisotropy No interventions administered. Device usability assessment only.
- Primary Outcome Measures
Name Time Method Exploratory device usability feedback 2 hours Identification of usability risks \[unscored\]
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rhaeos, Inc.
🇺🇸Chicago, Illinois, United States