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Formative Usability Assessment of Wireless Thermal Anisotropy Devices

Sponsor
Rhaeos, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06040697
Collaborator
(none)
145
Enrollment
7
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Thermal Anisotropy

Study Design

Study Type:
Observational
Anticipated Enrollment :
145 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Formative Usability Assessment of Wireless Thermal Anisotropy Devices Measuring Flow in Cerebrospinal Fluid Shunts
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Usability Assessment Cohort

No interventions administered. Device usability assessment only.

Device: Thermal Anisotropy
Usability assessment observation.
Other Names:
  • FlowSense

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Exploratory device usability feedback [2 hours]

      Identification of usability risks [unscored]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Rhaeos, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rhaeos, Inc.
    ClinicalTrials.gov Identifier:
    NCT06040697
    Other Study ID Numbers:
    • 2023-02
    First Posted:
    Sep 15, 2023
    Last Update Posted:
    Sep 22, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Hydrocephalus

    Study Results

    No Results Posted as of Sep 22, 2023