Vital Signs Patch Early Feasibility and Usability Study v1.0
NCT ID: NCT02524470
Last Updated: 2017-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
19 participants
INTERVENTIONAL
2014-07-31
2015-07-17
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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VSP Study Participants
Vital Signs Patch system study participants. Each study participant will receive the VSP System - NEHB Configuration and then the VSP System - PAL Configuration. Vital signs will be taken and adhesive will be assessed for each participant for each configuration.
VSP System - NEHB Configuration
VSP System - NEHB Configuration will take and record participant vital signs. NEHB is the last name of the physician who developed the configuration. It is not an acronym.
VSP System - PAL Configuration
VSP System - PAL Configuration will take and record patient vital signs. PAL is the name created by the engineering team of this device. It is not an acronym.
Interventions
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VSP System - NEHB Configuration
VSP System - NEHB Configuration will take and record participant vital signs. NEHB is the last name of the physician who developed the configuration. It is not an acronym.
VSP System - PAL Configuration
VSP System - PAL Configuration will take and record patient vital signs. PAL is the name created by the engineering team of this device. It is not an acronym.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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LifeWatch Services, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Raul Mitrani, MD FACC FHRS
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami, Miller School of Medicine
Miami, Florida, United States
Countries
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Other Identifiers
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VSP-F001v1.0
Identifier Type: -
Identifier Source: org_study_id
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