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Evaluation of EverOn™ System in Medical / Surgical Ward

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00640718
Recruitment Status : Withdrawn
First Posted : March 21, 2008
Last Update Posted : July 19, 2016
Information provided by:

Study Description
Brief Summary:

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.

Condition or disease
Post Operative Patient Patients Requiring PCA Respiratory Patients Patients in Risk of Fall

Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of EarlySense EverOn™ System in Medical / Surgical Ward
Study Start Date : March 2008
Estimated Primary Completion Date : March 2009
Estimated Study Completion Date : May 2010
Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults hospitalized in medical surgical units and are willing to sign consent form

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00640718

United States, Massachusetts
MetroWest Medical Center
Framingham, Massachusetts, United States, 01702-9167
Sponsors and Collaborators
EarlySense Ltd.
More Information

Additional Information:
Responsible Party: Dalia Argaman, EarlySense Ltd
ClinicalTrials.gov Identifier: NCT00640718     History of Changes
Other Study ID Numbers: ES-MRK-PROT1.1
First Posted: March 21, 2008    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: March 2008

Keywords provided by EarlySense Ltd.:
heart and respiratory monitoring