Formative Usability Assessment of Wireless Thermal Anisotropy Devices
ConditionHydrocephalus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-80
SponsorRhaeos, Inc.
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Presence of an interfering open wound in the device application region
Subject-reported history of adverse skin reactions to adhesives
Trial population
Subjects with an existing Cerebrospinal Fluid (CSF) shunt
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Thermal Anisotropy
DeviceUsability assessment observation.
Treatment groups
145 Participants
are divided into 1 treatment groupGroup A: Usability Assessment Cohort1 intervention
Trial outcomes
Primary outcomes
1
Exploratory device usability feedback
Identification of usability risks \[unscored\]
Time frame
2 hoursSponsors and contacts
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Source ClinicalTrials.gov