Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:11 PM
Study NCT ID:
NCT01515267
Status:
UNKNOWN
Last Update Posted:
2012-01-24
First Post:
2012-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Automated Left Ventricular Function Evaluation by LVivoEF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'lastUpdateSubmitDate': '2012-01-23', 'studyFirstSubmitDate': '2012-01-18', 'studyFirstSubmitQcDate': '2012-01-23', 'lastUpdatePostDateStruct': {'date': '2012-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-24', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['EF', 'EDV', 'ESV', 'Biplane', 'Echocardiography'], 'conditions': ['EF Evaluation From 4 Chamber Plane', 'EF Evaluation From 2 Chamber Plane', 'Biplane EF Evaluation', 'Left Ventricular Function']}, 'descriptionModule': {'briefSummary': 'Left ventricular ejection fraction (EF) is evaluated in every echocardiographic examination either by visual estimation (eyeballing) requiring high level of training and expertise and/or by manual tracing of the endocard from which EF is calculated (manual biplane method (MBP)). This procedure is subjective and time consuming. The objective of this study is to compare the performance of LVivoEF software system to the measurements obtained by the routinely used methods.', 'detailedDescription': 'LVivoEF is a decision support system (software) for automated global left ventricle (LV) systolic function evaluation from echocardiographic examinations. LVivoEF technology is based on a novel image processing algorithm for LV edge detection and ejection fraction (EF) evaluation. LVivoEF provides fully automated measurements of the left ventricle (LV) from two apical views the four chamber (4CH) and the two chamber (2CH).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients referred to an echocardiographic examination', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18\n* Patients referred to an echocardiographic examination. The patients will be consecutive until 30% of patients with normal LV function are enrolled. After that only consecutive patients with abnormal LV function will be included.\n\nExclusion Criteria:\n\n* Examinations in which more than one third of the endocard is not visible in a plane (2CH/4CH)\n* Patients with Left bundle branch block (LBBB)'}, 'identificationModule': {'nctId': 'NCT01515267', 'acronym': 'LVivoEF', 'briefTitle': 'Automated Left Ventricular Function Evaluation by LVivoEF', 'organization': {'class': 'INDUSTRY', 'fullName': 'DiA Imaging Analysis Ltd'}, 'officialTitle': 'Automated Left Ventricular Function Evaluation by LVivoEF', 'orgStudyIdInfo': {'id': 'DIA100'}}, 'contactsLocationsModule': {'locations': [{'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka university medical center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}], 'overallOfficials': [{'name': 'Noah Liel-Cohen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soroka University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DiA Imaging Analysis Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}