Vital Signs Patch Early Feasibility and Usability Study v1.0



Status:Completed
Healthy:No
Age Range:18 - Any
Updated:6/1/2017
Start Date:July 2014
End Date:July 17, 2015

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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.

Inclusion Criteria:

- Adult male and female in-patients with vital signs considered 'stable' by clinical
caregivers.

Exclusion Criteria:

- Pediatric patients

- Female patients who are pregnant

- Patients with internal or external defibrillators

- Patients who have undergone surgery and still have a fresh incision on the chest.

- Patients with skin damage on the chest such as burns, irritation, infections, wounds,
etc.

- Patients in the Critical Care Unit (CCU)

- Patients who otherwise satisfy any of the contraindications associated with the VSP
system.
We found this trial at
1
site
1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
Principal Investigator: Raul Mitrani, MD FACC FHRS
Phone: 305-243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
?
mi
from
Miami, FL
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