Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2026-01-29 @ 12:09 PM
Study NCT ID:
NCT02639468
Status:
TERMINATED
Last Update Posted:
2018-11-27
First Post:
2015-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electric Impedance Tomography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'protocol not fully appropriate technical issues with EIT device', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-26', 'studyFirstSubmitDate': '2015-12-17', 'studyFirstSubmitQcDate': '2015-12-21', 'lastUpdatePostDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of stroke volume values measured via pulmonary catheter compared to EIT-derived stroke volume estimates.', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stroke Volume']}, 'descriptionModule': {'briefSummary': 'Evaluation of electrical impedance tomography to non-invasively monitor stroke volume when compared to reference measurements performed via right heart thermodilution'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing cardiac surgery which requires placement of pulmonary catheter\n* Patients with right heart catheterization for diagnostic or therapeutic reasons\n\nExclusion Criteria:\n\n* Patient unable to understand the study\n* Patient unable to provide written consent or refusing his/her participation\n* Patient suffering from a severe valvular insufficiency\n* Patient allergic to ECG electrodes'}, 'identificationModule': {'nctId': 'NCT02639468', 'acronym': 'SVEIT', 'briefTitle': 'Electric Impedance Tomography', 'organization': {'class': 'INDUSTRY', 'fullName': "CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement"}, 'officialTitle': 'Electric Impedance Tomography', 'orgStudyIdInfo': {'id': 'SVEIT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tomographie par impédance électrique', 'description': 'Tomographie par impédance électrique', 'interventionNames': ['Device: Stroke Volume estimation using electrical impedance tomography']}], 'interventions': [{'name': 'Stroke Volume estimation using electrical impedance tomography', 'type': 'DEVICE', 'armGroupLabels': ['Tomographie par impédance électrique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'CHUV', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement", 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}