Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-02-27 @ 6:44 AM
Study NCT ID:
NCT00640718
Status:
WITHDRAWN
Last Update Posted:
2016-07-19
First Post:
2008-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of EverOn™ System in Medical / Surgical Ward
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2010-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-17', 'studyFirstSubmitDate': '2008-03-17', 'studyFirstSubmitQcDate': '2008-03-20', 'lastUpdatePostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['heart and respiratory monitoring'], 'conditions': ['Post Operative Patient', 'Patients Requiring PCA', 'Respiratory Patients', 'Patients in Risk of Fall']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ihi.org/ihi', 'label': 'Institute for Health Care Improvement (IHI)'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults hospitalized in medical surgical units and are willing to sign consent form', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age above 18 years.\n2. Patients not monitored continuously by telemetry, vital sign monitor or oximetry.\n3. Patients not requiring special mattresses (e.g. airflow).\n4. The patient or a legal guardian is ready to sign the Informed Consent.\n\nExclusion Criteria:\n\n1. Patients that at the judgment of the staff in the evaluating unit, are not able to communicate coherently and respond to nurses' questions.\n2. Patients monitored continuously by telemetry, vital sign monitor or oximetry.\n3. Patients requiring special mattresses."}, 'identificationModule': {'nctId': 'NCT00640718', 'briefTitle': 'Evaluation of EverOn™ System in Medical / Surgical Ward', 'organization': {'class': 'INDUSTRY', 'fullName': 'EarlySense Ltd.'}, 'officialTitle': 'Evaluation of EarlySense EverOn™ System in Medical / Surgical Ward', 'orgStudyIdInfo': {'id': 'ES-MRK-PROT1.1'}}, 'contactsLocationsModule': {'locations': [{'zip': '01702-9167', 'city': 'Framingham', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'MetroWest Medical Center', 'geoPoint': {'lat': 42.27926, 'lon': -71.41617}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EarlySense Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dalia Argaman', 'oldOrganization': 'EarlySense Ltd'}}}}