Usability Clinical Trial
Official title:
Non-Contact Monitoring of Subjects With an Optical Device: A Pilot Usability Study
This is a single-center, prospective study in subjects visiting TASMC for various
indications.
This study will be divided into two arms:
First Arm - Subjects measured by the study staff via the investigational device at the
hospital (up to 50 subjects).
Second Arm - subjects measuring themselves autonomously with the investigational device at
their homes (up to 10 subjects from the first arm).
Hence, total number of subjects for the study will be up to N=50. All subjects will be
enrolled to the study only after signing an informed consent form.
Specifically for the second arm, subjects will undergo proper training by the sponsor's
representatives prior to being discharged from the hospital. Training will focus on proper
operation of the device, which is also designed for autonomous use in a simple and
user-friendly manner. Subjects will be asked to monitor themselves periodically for a
duration of up to a week. Ongoing support will be provided by the sponsor upon subject
request, either by phone, or on-premise via a dedicated support team.
For both arms, device users (either study staff in first arm or subjects in the second arm)
will be requested to answer questionnaires in order to assess usability with the
investigational device. In both cases, a dedicated sponsor representative will observe the
users to gather objective usability data, and aid in the questionnaire filling process.
n/a
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