Vital Signs Patch Early Feasibility and Usability Study v1.0 (VSP)

LifeWatch Services

Status: Completed

Conditions: Vital Signs

Treatments: Device: VSP System - PAL Configuration; Device: VSP System - NEHB Configuration

Study type: Interventional

Funder types: Industry

Identifiers

NCT02524470

VSP-F001v1.0

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

VSP Study Participants

Experimental group

Description:

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.

Treatment:

Device: VSP System - PAL Configuration

Device: VSP System - NEHB Configuration