Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT00196105
Status:
COMPLETED
Last Update Posted:
2011-10-03
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D041781', 'term': 'Jaundice, Obstructive'}, {'id': 'D007565', 'term': 'Jaundice'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006932', 'term': 'Hyperbilirubinemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ssnyder@medinst.com', 'phone': '765-463-7537', 'title': 'Scott Snyder', 'organization': 'Cook'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'No adverse events were captured due to terminal patients.', 'eventGroups': [{'id': 'EG000', 'title': '6 mm Zilver', 'description': '6 mm Nitinol Zilver Stent', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '10 mm Zilver', 'description': '10 mm Nitinol Zilver Stent', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '10 mm Wallstent', 'description': '10 mm Stainless Steel Wallstent', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '6 mm Zilver', 'description': '6 mm Nitinol Zilver Stent'}, {'id': 'OG001', 'title': '10 mm Zilver', 'description': '10 mm Nitinol Zilver Stent'}, {'id': 'OG002', 'title': '10 mm Wallstent', 'description': '10 mm Stainless Steel Wallstent'}], 'classes': [{'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '595'}, {'value': '125.5', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '671'}, {'value': '121', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '961'}]}]}], 'analyses': [{'pValue': '.057', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 32 months', 'description': 'Number of days of stent patency: The time to stent occlusion requiring re-intervention, death, loss to follow-up, or patients alive at study end without an occlusion (\\>= 6 months after placement).', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Closure or Blockage of the Stent (Occlusion)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '6 mm Zilver', 'description': '6 mm Nitinol Zilver Stent'}, {'id': 'OG001', 'title': '10 mm Zilver', 'description': '10 mm Nitinol Zilver Stent'}, {'id': 'OG002', 'title': '10 mm Wallstent', 'description': '10 mm Stainless Steel Wallstent'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.04', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.007', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'Death is censored for Kaplan-Meier analysis.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.69', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.02', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'P-value is adjusted for multiple comparisons.', 'groupDescription': '6 mm Zilver vs. 10 mm Zilver and 10 mm Wallstent combined', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'up to 32 months', 'description': 'Biliary stents may become closed or blocked. This is also termed "Occlusion." Data for this outcome measure involve stent occlusions that required re-intervention.', 'unitOfMeasure': 'Stent Occlusions', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Days to Occlusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '6 mm Zilver', 'description': '6 mm Nitinol Zilver Stent'}, {'id': 'OG001', 'title': '10 mm Zilver', 'description': '10 mm Nitinol Zilver Stent'}, {'id': 'OG002', 'title': '10 mm Wallstent', 'description': '10 mm Stainless Steel Wallstent'}], 'classes': [{'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '595'}, {'value': '111', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '506'}, {'value': '103', 'groupId': 'OG002', 'lowerLimit': '7', 'upperLimit': '386'}]}]}], 'analyses': [{'pValue': '.16', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 32 months', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '6 mm Zilver', 'description': '6 mm Nitinol Zilver Stent'}, {'id': 'OG001', 'title': '10 mm Zilver', 'description': '10 mm Nitinol Zilver Stent'}, {'id': 'OG002', 'title': '10 mm Wallstent', 'description': '10 mm Stainless Steel Wallstent'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 32 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Time to Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '6 mm Zilver', 'description': '6 mm Nitinol Zilver Stent'}, {'id': 'OG001', 'title': '10 mm Zilver', 'description': '10 mm Nitinol Zilver Stent'}, {'id': 'OG002', 'title': '10 mm Wallstent', 'description': '10 mm Stainless Steel Wallstent'}], 'classes': [{'categories': [{'measurements': [{'value': '132.6', 'groupId': 'OG000', 'lowerLimit': '74', 'upperLimit': '328'}, {'value': '186', 'groupId': 'OG001', 'lowerLimit': '92', 'upperLimit': '304'}, {'value': '170', 'groupId': 'OG002', 'lowerLimit': '99', 'upperLimit': '273'}]}]}], 'analyses': [{'pValue': '.32', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.69', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 32 months', 'description': 'Overall Survival', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '6 mm Zilver', 'description': '6 mm Nitinol Zilver Stent'}, {'id': 'FG001', 'title': '10 mm Zilver', 'description': '10 mm Nitinol Zilver Stent'}, {'id': 'FG002', 'title': '10 mm Wallstent', 'description': '10 mm Stainless Steel Wallstent'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '88'}, {'groupId': 'FG002', 'numSubjects': '89'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '83'}, {'groupId': 'FG002', 'numSubjects': '82'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '241', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '6 mm Zilver', 'description': '6 mm Nitinol Zilver Stent'}, {'id': 'BG001', 'title': '10 mm Zilver', 'description': '10 mm Nitinol Zilver Stent'}, {'id': 'BG002', 'title': '10 mm Wallstent', 'description': '10 mm Stainless Steel Wallstent'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.3', 'groupId': 'BG000', 'lowerLimit': '41', 'upperLimit': '90'}, {'value': '72.8', 'groupId': 'BG001', 'lowerLimit': '48', 'upperLimit': '94'}, {'value': '71.5', 'groupId': 'BG002', 'lowerLimit': '49', 'upperLimit': '96'}, {'value': '71.9', 'groupId': 'BG003', 'lowerLimit': '41', 'upperLimit': '96'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '115.0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '126.0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Biliary Sphincterotomy', 'classes': [{'title': 'Patients with Biliary Sphincterotomy', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}]}]}, {'title': 'Patients without Biliary Sphincterotomy', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Previous Plastic Stent', 'classes': [{'title': 'Patients with Previous Plastic Stent', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}]}, {'title': 'Patients without Previous Plastic Stent', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '127', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Tumor Diagnosis', 'classes': [{'title': 'Patients with Pancreatic Cancer', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '181', 'groupId': 'BG003'}]}]}, {'title': 'Patients with Metastatic Cancer', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}, {'title': 'Patients with Cholangiocarcinoma', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}, {'title': 'Patients with Gallbladder Cancer', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Patients with Other Cancer', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'Patients without Tumor', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Bilirubin', 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'spread': '8.7', 'groupId': 'BG000'}, {'value': '8.7', 'spread': '7.3', 'groupId': 'BG001'}, {'value': '8.3', 'spread': '8.7', 'groupId': 'BG002'}, {'value': '8.8', 'spread': '8.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Karnofsky Index', 'classes': [{'categories': [{'measurements': [{'value': '80.5', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '80.6', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '81.2', 'spread': '9.2', 'groupId': 'BG002'}, {'value': '80.8', 'spread': '9.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Karnofsky index runs from 100 to 0, where 100 is "perfect" health and 0 is death.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 241}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-28', 'studyFirstSubmitDate': '2005-09-12', 'resultsFirstSubmitDate': '2009-09-25', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2011-10-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-01-11', 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patency', 'timeFrame': 'up to 32 months', 'description': 'Number of days of stent patency: The time to stent occlusion requiring re-intervention, death, loss to follow-up, or patients alive at study end without an occlusion (\\>= 6 months after placement).'}, {'measure': 'Closure or Blockage of the Stent (Occlusion)', 'timeFrame': 'up to 32 months', 'description': 'Biliary stents may become closed or blocked. This is also termed "Occlusion." Data for this outcome measure involve stent occlusions that required re-intervention.'}, {'measure': 'Number of Days to Occlusion', 'timeFrame': 'up to 32 months'}, {'measure': 'Number of Deaths', 'timeFrame': 'up to 32 months'}, {'measure': 'Time to Death', 'timeFrame': 'up to 32 months', 'description': 'Overall Survival'}]}, 'conditionsModule': {'keywords': ['Stents', 'Stent-graft', 'Minimally invasive', 'Biliary Tract Cancer', 'Pancreatic Cancer', 'Jaundice', 'Biliary Tract Neoplasms', 'Pancreatic Neoplasms', 'Jaundice, Obstructive', 'Zilver'], 'conditions': ['Biliary Tract Neoplasms', 'Pancreatic Neoplasms', 'Jaundice, Obstructive']}, 'referencesModule': {'references': [{'pmid': '19482279', 'type': 'RESULT', 'citation': 'Loew BJ, Howell DA, Sanders MK, Desilets DJ, Kortan PP, May GR, Shah RJ, Chen YK, Parsons WG, Hawes RH, Cotton PB, Slivka AA, Ahmad J, Lehman GA, Sherman S, Neuhaus H, Schumacher BM. Comparative performance of uncoated, self-expanding metal biliary stents of different designs in 2 diameters: final results of an international multicenter, randomized, controlled trial. Gastrointest Endosc. 2009 Sep;70(3):445-53. doi: 10.1016/j.gie.2008.11.018. Epub 2009 May 30.'}]}, 'descriptionModule': {'briefSummary': 'This study compares the 6 mm nitinol Zilver biliary endoprostheses and the 10 mm nitinol Zilver biliary endoprostheses to the 10 mm Wallstent in appropriate patients in need of palliative treatment of malignant obstructive jaundice.', 'detailedDescription': 'This research is being done to determine if the new, FDA-cleared Zilver metal biliary stent is better than the conventional stents. The new Zilver stent may permit more accurate placement, may avoid some potential complications and last longer than the conventional stents. The study will also examine to find the best diameter of stent by comparing standard 10 mm stents to 6 mm Zilver stents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unresectable malignancy of the extrahepatic bile duct\n\nExclusion Criteria:\n\n* Age below 21 years\n* Pregnancy\n* Active alcohol or drug abuse\n* Simultaneously participating in another investigational drug or device study.\n* Allergy to stainless steel or nitinol\n* Active cholangitis\n* Brachytherapy\n* Unable or unwilling to comply with follow up'}, 'identificationModule': {'nctId': 'NCT00196105', 'briefTitle': 'Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cook Group Incorporated'}, 'officialTitle': 'Multicenter Prospective Randomized Controlled Trial of the Nitinol ZILVER Expandable Endoprosthesis in the Palliation of Extrahepatic Malignant Biliary Obstruction', 'orgStudyIdInfo': {'id': '03-MOZ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '6 mm Zilver', 'description': '6 mm Nitinol Zilver Stent', 'interventionNames': ['Device: 6 mm Nitinol Zilver Stent']}, {'type': 'EXPERIMENTAL', 'label': '10 mm Zilver', 'description': '10 mm Nitinol Zilver Stent', 'interventionNames': ['Device: 10 mm Nitinol Zilver Stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': '10 mm Wallstent', 'description': '10 mm Stainless Steel Wallstent', 'interventionNames': ['Device: 10 mm Stainless Steel Wallstent']}], 'interventions': [{'name': '6 mm Nitinol Zilver Stent', 'type': 'DEVICE', 'armGroupLabels': ['6 mm Zilver']}, {'name': '10 mm Nitinol Zilver Stent', 'type': 'DEVICE', 'armGroupLabels': ['10 mm Zilver']}, {'name': '10 mm Stainless Steel Wallstent', 'type': 'DEVICE', 'armGroupLabels': ['10 mm Wallstent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04102', 'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'facility': 'Maine Medical Center', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}], 'overallOfficials': [{'name': 'Douglas Howell, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MaineHealth'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cook Group Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}