Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-28 @ 1:23 PM
Study NCT ID:
NCT01343160
Status:
COMPLETED
Last Update Posted:
2021-04-21
First Post:
2011-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rafzal@wlgore.com', 'phone': '623-234-5408', 'title': 'Rizwan Afzal', 'organization': 'W.L. Gore & Associates'}, 'certainAgreement': {'otherDetails': 'Sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. Sponsor can require changes to the communication as necessary to ensure the proper use of any references to itself, its trademarks, and trade names and to correct inaccuracies in any technical specifications or descriptions of the device, including its component materials.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for patients upto 12 Months of treatment period with the stent and upto 15 Months of post stent removal', 'eventGroups': [{'id': 'EG000', 'title': 'GORE VIABIL', 'description': 'GORE® VIABIL® Biliary Endoprosthesis', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 6, 'seriousNumAtRisk': 36, 'deathsNumAffected': 2, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Recurrence of obstructive jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Papillary hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safe Stent Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GORE VIABIL', 'description': 'GORE® VIABIL® Biliary Endoprosthesis'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Upon Removal', 'description': 'The stent removal is considered safe when the Study Device is removed successfully and without SAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with stent removal data available'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Primary Device Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GORE VIABIL', 'description': 'GORE® VIABIL® Biliary Endoprosthesis'}], 'classes': [{'categories': [{'measurements': [{'value': '77.7', 'groupId': 'OG000', 'lowerLimit': '55.9', 'upperLimit': '89.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'description': 'Primary device patency is defined as the freedom from device occlusion requiring intervention (during the treatment period).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Successful Delivery and Deployment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GORE VIABIL® Biliary Endoprosthesis', 'description': 'Placement of GORE VIABIL® Biliary Endoprosthesis to establish duct patency\n\nGORE® VIABIL® Biliary Endoprosthesis: Deployment of GORE® VIABIL® Biliary Endoprosthesis to the area of stricture'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Upon Implant', 'description': 'This requires successful delivery and deployment of the device at the intended site.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Successful Treatment of Benign Stricture Upon Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GORE VIABIL', 'description': 'GORE® VIABIL® Biliary Endoprosthesis'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Upon implant', 'description': 'Successful treatment of strictures is defined as stricture resolution upon implant as reported by the PI. For the purpose of this report, we will be referring to this as "stented stricture resolution".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Secondary Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GORE VIABIL', 'description': 'GORE® VIABIL® Biliary Endoprosthesis'}], 'classes': [{'categories': [{'measurements': [{'value': '84.3', 'groupId': 'OG000', 'lowerLimit': '62.5', 'upperLimit': '93.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Viability of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GORE VIABIL', 'description': 'GORE® VIABIL® Biliary Endoprosthesis'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Upon Removal', 'description': 'Treatment is considered viable when the Study Device is removed and the structure is either resolved or improved without the need for re-stenting at the time of Study Device removal.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with stent removal data available'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Secondary Patency Post Study Device Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GORE VIABIL', 'description': 'GORE® VIABIL® Biliary Endoprosthesis'}], 'classes': [{'categories': [{'measurements': [{'value': '67.8', 'groupId': 'OG000', 'lowerLimit': '48.0', 'upperLimit': '81.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 Months', 'description': 'Secondary patency post study device removal is defined as the absence of stricture recurrence from time of Study Device removal to study completion or lost to follow up. Secondary Patency is also known as Long Term Stricture Resolution.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Primary Patency of Treated Stricture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GORE VIABIL', 'description': 'GORE® VIABIL® Biliary Endoprosthesis'}], 'classes': [{'categories': [{'measurements': [{'value': '64.8', 'groupId': 'OG000', 'lowerLimit': '45.2', 'upperLimit': '78.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 Months', 'description': 'Primary patency of the treated stricture is defined as freedom from stricture intervention due to occlusion following Study Device removal.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GORE VIABIL® Biliary Endoprosthesis', 'description': 'Placement of GORE VIABIL® Biliary Endoprosthesis to establish duct patency\n\nGORE® VIABIL® Biliary Endoprosthesis: Deployment of GORE® VIABIL® Biliary Endoprosthesis to the area of stricture'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'GORE VIABIL', 'description': 'GORE® VIABIL® Biliary Endoprosthesis'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.9', 'spread': '12.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '07', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-25', 'studyFirstSubmitDate': '2011-02-14', 'resultsFirstSubmitDate': '2021-03-25', 'studyFirstSubmitQcDate': '2011-04-26', 'lastUpdatePostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-25', 'studyFirstPostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Primary Device Patency', 'timeFrame': '12 Months', 'description': 'Primary device patency is defined as the freedom from device occlusion requiring intervention (during the treatment period).'}, {'measure': 'Successful Delivery and Deployment', 'timeFrame': 'Upon Implant', 'description': 'This requires successful delivery and deployment of the device at the intended site.'}, {'measure': 'Successful Treatment of Benign Stricture Upon Implant', 'timeFrame': 'Upon implant', 'description': 'Successful treatment of strictures is defined as stricture resolution upon implant as reported by the PI. For the purpose of this report, we will be referring to this as "stented stricture resolution".'}, {'measure': 'Secondary Patency', 'timeFrame': '12 Months'}, {'measure': 'Viability of Treatment', 'timeFrame': 'Upon Removal', 'description': 'Treatment is considered viable when the Study Device is removed and the structure is either resolved or improved without the need for re-stenting at the time of Study Device removal.'}, {'measure': 'Secondary Patency Post Study Device Removal', 'timeFrame': '15 Months', 'description': 'Secondary patency post study device removal is defined as the absence of stricture recurrence from time of Study Device removal to study completion or lost to follow up. Secondary Patency is also known as Long Term Stricture Resolution.'}, {'measure': 'Primary Patency of Treated Stricture', 'timeFrame': '15 Months', 'description': 'Primary patency of the treated stricture is defined as freedom from stricture intervention due to occlusion following Study Device removal.'}], 'primaryOutcomes': [{'measure': 'Safe Stent Removal', 'timeFrame': 'Upon Removal', 'description': 'The stent removal is considered safe when the Study Device is removed successfully and without SAEs.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Biliary Strictures']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to generate clinical data to support the use of GORE® VIABIL® Biliary Endoprosthesis in the endoscopic and percutaneous treatment of benign biliary strictures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is diagnosed with treatable benign biliary stricture which necessitates the need for implantation of a biliary endoprosthesis\n* Subject is ≥18 years of age\n* Subject is able to comply with study protocol and follow-up requirements\n* Written informed consent is obtained using the Investigational Review Board (IRB)/Ethics Committee (EC) approved consent form\n\nExclusion Criteria:\n\n* Subject anatomy ruling out covered self expanding metal stent use (e.g. above hilar region)\n* Treatment of stricture would require placement of a covered biliary endoprosthesis within a previously placed bare metal stent\n* The subject has malignant biliary disease\n* Subject has known pregnancy\n* Participated in protocol involving investigational drug or device within 90 days prior to entry into this study'}, 'identificationModule': {'nctId': 'NCT01343160', 'briefTitle': 'Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures', 'organization': {'class': 'INDUSTRY', 'fullName': 'W.L.Gore & Associates'}, 'officialTitle': 'Multicenter Study of Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures', 'orgStudyIdInfo': {'id': 'VBR CS 156'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'GORE VIABIL® Biliary Endoprosthesis', 'description': 'Placement of GORE VIABIL® Biliary Endoprosthesis to establish duct patency', 'interventionNames': ['Device: GORE® VIABIL® Biliary Endoprosthesis']}], 'interventions': [{'name': 'GORE® VIABIL® Biliary Endoprosthesis', 'type': 'DEVICE', 'description': 'Deployment of GORE® VIABIL® Biliary Endoprosthesis to the area of stricture', 'armGroupLabels': ['GORE VIABIL® Biliary Endoprosthesis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ludwigsburg', 'country': 'Germany', 'facility': 'Klinikum Ludwigsburg', 'geoPoint': {'lat': 48.89731, 'lon': 9.19161}}], 'overallOfficials': [{'name': 'Karel Caca, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum Ludwigsburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'W.L.Gore & Associates', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}