Evaluation of EverOn™ System in Medical / Surgical Ward

July 17, 2016 updated by: EarlySense Ltd.

Evaluation of EarlySense EverOn™ System in Medical / Surgical Ward

The EverOn™ system developed by EarlySense, Ltd., the sponsor of this study, is intended to assist hospitals to better address and improve recognition and response to changes in a patient's condition.

The system, monitors the patient while in bed consists of a contact-free sensor that is placed under the bed mattress and identifies respiratory and heart rates, degree of patient's movement or agitation while in bed as well as patient's actual exit out of the bed. The EverOn system does not require a physical contact with the patient, eliminating the need for any direct contact electrodes, leads, cuffs or nasal cannulae.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Framingham, Massachusetts, United States, 01702-9167
        • MetroWest Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults hospitalized in medical surgical units and are willing to sign consent form

Description

Inclusion Criteria:

  1. Age above 18 years.
  2. Patients not monitored continuously by telemetry, vital sign monitor or oximetry.
  3. Patients not requiring special mattresses (e.g. airflow).
  4. The patient or a legal guardian is ready to sign the Informed Consent.

Exclusion Criteria:

  1. Patients that at the judgment of the staff in the evaluating unit, are not able to communicate coherently and respond to nurses' questions.
  2. Patients monitored continuously by telemetry, vital sign monitor or oximetry.
  3. Patients requiring special mattresses.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EarlySense Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ANTICIPATED)

March 1, 2009

Study Completion (ANTICIPATED)

May 1, 2010

Study Registration Dates

First Submitted

March 17, 2008

First Submitted That Met QC Criteria

March 20, 2008

First Posted (ESTIMATE)

March 21, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 17, 2016

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ES-MRK-PROT1.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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