Vital Signs Clinical Trial
Official title:
Feasibility Study for Automated Monitoring of Vital Signs Measurements in the In-Patient Hospital Setting v1.0
To assess the feasibility and usability of the Vital Signs Patch (VSP) System in the in-patient hospital setting to monitor vital signs using a patch, brain, gateway, and console. The VSP System will be incorporated into the study site's Information Technology infrastructure.
The primary objective of this clinical feasibility study is to evaluate the feasibility of
the Vital Signs Patch System (VSP). The VSP will be incorporated into the study site's
Information Technology infrastructure and worn by in-patients for a minimum of 3 days and
for the duration of their hospital stay up to 7 days.
The VSP will take and monitor vital signs in addition to the normal equipment the facility
uses to monitor and take vital signs. This study will not be assessing safety and no
comparator groups will be used. As this study will not be treating any particular disease or
condition, no randomization or blinding is required. Subjects will be chosen as they are
admitted in accordance with the general population characteristics, inclusion and exclusion
criteria and willingness to sign the Informed Consent.
This clinical study involves a device with no additional drugs administered.
During this study, a single VSP System patch will be worn for up to 48 hours. The first
patch will be placed using the NEHB configuration. After the first 48 hours, the
NEHB-configured patch will be replaced with a new patch in the PAL configuration. The second
patch can remain on the subject for the duration of the subject's hospital stay, or up to
seven (7) consecutive days. Individual patient use will determine the duration of time that
the second patch can be worn.
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