Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-03-03 @ 4:33 AM
Study NCT ID:
NCT01457105
Status:
COMPLETED
Last Update Posted:
2011-10-21
First Post:
2011-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Covered Self-expandable Metal Stents for Palliation of Malignant Biliary Strictures: Evaluation of a New Type of Stent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-20', 'studyFirstSubmitDate': '2011-10-19', 'studyFirstSubmitQcDate': '2011-10-20', 'lastUpdatePostDateStruct': {'date': '2011-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patency and effectiveness of the ComVi stent in palliation of jaundice in patients with malignant biliary strictures', 'timeFrame': 'two years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Malignant strictures of the main biliary duct'], 'conditions': ['Malignant Biliary Strictures']}, 'descriptionModule': {'briefSummary': 'self-expandable metal stents for palliation of malignant biliary strictures', 'detailedDescription': 'The ComVi biliary stent (Taewoong Medical Inc., Seoul, Korea), is a covered metallic stent with a expanded polytetrafluoroethylene (e-PTFE) membrane sandwiched between two wire layers and has a weaker axial force than other stents.\n\nPatients with middle-distal malignant biliary stricture and with symptoms as jaundice, itching and pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with malignant stenosis at the middle or lower third of the common bile duct inoperable and/or unresectable.\n* Patients without liver metastases and 6 months life expectancy\n* Patients at the first attempt of endoscopic biliary drainage.\n* Negative history for biliary tract surgery.\n\nExclusion Criteria:\n\n* Patients with ampullary cancer.\n* Patients with hilar and/or intra-hepatic ducts malignancy.\n* Patients with haemobilia.\n* Patients with acute cholangitis at the time of stenting.\n* Patients with previous percutaneous, endoscopic or surgical biliary drainage.'}, 'identificationModule': {'nctId': 'NCT01457105', 'briefTitle': 'Covered Self-expandable Metal Stents for Palliation of Malignant Biliary Strictures: Evaluation of a New Type of Stent', 'organization': {'class': 'OTHER', 'fullName': 'Catholic University of the Sacred Heart'}, 'officialTitle': 'PARTIALLY COVERED NITINOL "ComVi" STENT FOR PALLIATION OF MALIGNANT NON HILAR BILIARY OBSTRUCTION', 'orgStudyIdInfo': {'id': 'A/1531/05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ComVi biliary stent', 'interventionNames': ['Device: Endoscopic retrograde cholangiography (ERC) (ComVi biliary stent)']}], 'interventions': [{'name': 'Endoscopic retrograde cholangiography (ERC) (ComVi biliary stent)', 'type': 'DEVICE', 'description': 'Metal stents placement in the main biliary duct during ERC', 'armGroupLabels': ['ComVi biliary stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'state': 'RM', 'country': 'Italy', 'facility': 'Catholic University', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catholic University of the Sacred Heart', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Professor Guido Costamagna', 'investigatorAffiliation': 'Catholic University of the Sacred Heart'}}}}