Vital Signs Patch Early Feasibility and Usability Study v1.0

NCT02524470 | Completed FDA Device

• 1 other identifier: VSP-F001v1.0
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vital Signs

Outcome Measures

Primary Outcomes (1)

• Composite Outcome Measure - 100% Successful Vital Signs Acquisition

  Successful acquisition of Temperature, Heart Rate, ECG, Respiration, and SpO2 daily for the inpatient stay of the subject up to seven days. Success is achieved if all vital signs are obtained on a study participant. It is a composite result.

  Up to seven days

Secondary Outcomes (1)

• Composite Outcome Measure - Adhesive Performance - Measurement of skin irritation resulting from adhesive used with electrodes.

  Up to seven days

Study Arms (1)

VSP Study Participants

EXPERIMENTAL

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.

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

Interventions

VSP System - NEHB Configuration DEVICE

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 Study Participants

VSP System - PAL Configuration DEVICE

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.

VSP Study Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• LifeWatch Services, Inc.: lead

Study Sites (1)

University of Miami, Miller School of Medicine

Miami, Florida, 33136, United States

Location

Study Officials

• Raul Mitrani, MD FACC FHRS

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: August 14, 2015
• Study Start: July 1, 2014
• Primary Completion: July 17, 2015
• Study Completion: July 17, 2015
• Last Updated: May 31, 2017

Record last verified: 2017-05

Locations

US (1)