Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2026-02-20 @ 11:49 PM
Study NCT ID:
NCT02269995
Status:
COMPLETED
Last Update Posted:
2018-11-05
First Post:
2014-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-marketing Surveillance of DC Bead in Patients With Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-12-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-02', 'studyFirstSubmitDate': '2014-08-22', 'studyFirstSubmitQcDate': '2014-10-17', 'lastUpdatePostDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability as measured by Adverse Events', 'timeFrame': 'Up to 30 days'}], 'secondaryOutcomes': [{'measure': 'Efficacy of DC bead as assessed by embolic performance', 'timeFrame': 'Up to 30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatocellular', 'Carcinoma'], 'conditions': ['Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Jpn J Intervent Radiol. 2017;32:136-141.'}]}, 'descriptionModule': {'briefSummary': "This surveillance's objectives are:\n\n1. Unknown adverse reactions\n2. Incidences of adverse drug reaction\n3. Factors considered to have effect to safety and effectiveness"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Hepatocellular carcinoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nPatients with Hepatocellular carcinoma\n\nExclusion criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT02269995', 'briefTitle': 'Post-marketing Surveillance of DC Bead in Patients With Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'orgStudyIdInfo': {'id': 'DCB01S'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'E7040', 'interventionNames': ['Device: E7040']}], 'interventions': [{'name': 'E7040', 'type': 'DEVICE', 'otherNames': ['DC Beads'], 'description': 'E7040 of optimal particle size (-300 um, 300-500 um, or 500-700 um to fit in a target vessel, target lesion, or embolized area) as transcatheter study device will be administered .', 'armGroupLabels': ['E7040']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Japan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}