Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT00713427
Status:
COMPLETED
Last Update Posted:
2021-07-30
First Post:
2008-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003251', 'term': 'Constriction, Pathologic'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Joyce.Peetermans@bsci.com', 'phone': '508-683-4211', 'title': 'Joyce Peetermans, PhD - Vice President, Global Clinical Programs', 'organization': 'Boston Scientific Corporation'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data collected from the time the participant signed the informed consent until completion of the 6 month follow-up visit (occurring 6 months post-initial study treatment)', 'description': 'Reported on Adverse Events (Serious and Non-serious) related to the device and/or procedure.', 'eventGroups': [{'id': 'EG000', 'title': 'WallFlex Stent', 'description': 'All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted.\n\nWallFlex™ Biliary Partially-Covered Stent: Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent.', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 0, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'seriousEvents': [{'term': 'Recurrent Biliary Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Right Upper Quadrant Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Absence of Recurrent Biliary Obstruction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'WallFlex Stent', 'description': 'All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted.\n\nWallFlex™ Biliary Partially-Covered Stent: Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent.'}], 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 6 months post treatment or prior to death, whichever came first', 'description': 'Defined as absence of recurrent biliary obstruction defined as absence of biliary symptoms. Biliary symptoms, included, but were not limited to jaundice, itching, right upper quadrant abdominal pain, nausea, vomiting, fever, and dark urine. Symptom assessment occurred during the Screening/Baseline period and at all follow-up time points.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events Related to the Device and/or Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'WallFlex Stent', 'description': 'All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted.\n\nWallFlex™ Biliary Partially-Covered Stent: Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time participant signs informed consent until time participant exits study (up to 6 months following stent placement)', 'description': 'Number of adverse events (serious and non-serious) related to the device and/or procedure were collected following informed consent, treatment, and at all follow-up timepoints.', 'unitOfMeasure': 'related adverse events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Technical Stent Placement Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'WallFlex Stent', 'description': 'All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted.\n\nWallFlex™ Biliary Partially-Covered Stent: Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent.'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Initial stent placement procedure', 'description': 'Technical stent placement success defined as the ability to deploy the stent in satisfactory position across the stricture', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Occurrence of Re-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'WallFlex Stent', 'description': 'All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted.\n\nWallFlex™ Biliary Partially-Covered Stent: Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 6 months post-initial study treatment', 'description': 'A re-intervention is defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage after insertion of the initial study stent. Re-intervention does not include a second WallFlex stent placement during the 7 days post initial placement as a second stent could have been placed due to misplacement or failure to cover the entire stricture.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Biliary Obstruction Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'WallFlex Stent', 'description': 'All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted.\n\nWallFlex™ Biliary Partially-Covered Stent: Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent.'}], 'classes': [{'categories': [{'measurements': [{'value': '.62', 'spread': '.98', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 6 months post-initial study treatment', 'description': 'Incidence of symptoms of biliary obstruction', 'unitOfMeasure': 'count of symptoms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Recurrent Biliary Obstruction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'WallFlex Stent', 'description': 'All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted.\n\nWallFlex™ Biliary Partially-Covered Stent: Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent.'}], 'classes': [{'categories': [{'measurements': [{'value': '110', 'spread': '63', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 6 months', 'description': 'Biliary obstruction symptoms were collected at all follow-up visits post treatment and included but not limited to jaundice, itching, right upper quadrant abdominal pain, nausea, vomiting, fever, and dark urine. The time to recurrent biliary obstruction was recorded.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'WallFlex Stent', 'description': 'All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted.\n\nWallFlex™ Biliary Partially-Covered Stent: Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '2.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month following stent placement', 'description': 'Bilirubin change at 1 month following stent placement as assessed against bilirubin at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'WallFlex Stent', 'description': 'All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted.\n\nWallFlex™ Biliary Partially-Covered Stent: Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'WallFlex Stent', 'description': 'All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted.\n\nWallFlex™ Biliary Partially-Covered Stent: Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '68.6', 'groupId': 'BG000', 'lowerLimit': '34', 'upperLimit': '92'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Malignant cause of bile duct stricture', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Pancreatic', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}, {'title': 'Cholangiocarcinoma', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Ampullary', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Gallbladder', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Metastases from colon', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Primary liver cancer invading common bile duct', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Metastases from esophageal', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Metastases from lung', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Metastases from breast', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Stricture location', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Distal common bile duct', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}, {'title': 'Mid common bile duct', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Papilla', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Proximal common bile duct', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of study stents placed', 'classes': [{'title': 'number of 60mm x10mm stents placed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}, {'title': 'number of 40mm x 10mm stents placed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'number of 80mm x10mm stents placed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'number of 60mm x 8mm stents placed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'A total of 71 stents were placed, as two of the study participants required two stents to be placed due to the length of their strictures.', 'unitOfMeasure': 'Stents'}], 'populationDescription': '70 patients were enrolled, of whom 69 received a stent and were evaluated for baseline characteristics.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-15', 'studyFirstSubmitDate': '2008-07-09', 'resultsFirstSubmitDate': '2021-05-10', 'studyFirstSubmitQcDate': '2008-07-09', 'lastUpdatePostDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-10', 'studyFirstPostDateStruct': {'date': '2008-07-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Absence of Recurrent Biliary Obstruction', 'timeFrame': 'Up to 6 months post treatment or prior to death, whichever came first', 'description': 'Defined as absence of recurrent biliary obstruction defined as absence of biliary symptoms. Biliary symptoms, included, but were not limited to jaundice, itching, right upper quadrant abdominal pain, nausea, vomiting, fever, and dark urine. Symptom assessment occurred during the Screening/Baseline period and at all follow-up time points.'}], 'secondaryOutcomes': [{'measure': 'Number of Adverse Events Related to the Device and/or Procedure', 'timeFrame': 'From time participant signs informed consent until time participant exits study (up to 6 months following stent placement)', 'description': 'Number of adverse events (serious and non-serious) related to the device and/or procedure were collected following informed consent, treatment, and at all follow-up timepoints.'}, {'measure': 'Number of Participants With Technical Stent Placement Success', 'timeFrame': 'Initial stent placement procedure', 'description': 'Technical stent placement success defined as the ability to deploy the stent in satisfactory position across the stricture'}, {'measure': 'Number of Participants With Occurrence of Re-intervention', 'timeFrame': 'Up to 6 months post-initial study treatment', 'description': 'A re-intervention is defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage after insertion of the initial study stent. Re-intervention does not include a second WallFlex stent placement during the 7 days post initial placement as a second stent could have been placed due to misplacement or failure to cover the entire stricture.'}, {'measure': 'Change in Biliary Obstruction Symptoms', 'timeFrame': 'up to 6 months post-initial study treatment', 'description': 'Incidence of symptoms of biliary obstruction'}, {'measure': 'Time to Recurrent Biliary Obstruction', 'timeFrame': 'Up to 6 months', 'description': 'Biliary obstruction symptoms were collected at all follow-up visits post treatment and included but not limited to jaundice, itching, right upper quadrant abdominal pain, nausea, vomiting, fever, and dark urine. The time to recurrent biliary obstruction was recorded.'}, {'measure': 'Change in Bilirubin', 'timeFrame': '1 month following stent placement', 'description': 'Bilirubin change at 1 month following stent placement as assessed against bilirubin at baseline.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Biliary', 'Strictures', 'Malignant', 'Neoplasm', 'Palliation'], 'conditions': ['Biliary Strictures Caused by Malignant Neoplasms']}, 'descriptionModule': {'briefSummary': 'This is a a prospective study of the WallFlex™ Biliary Partially-covered Stent designed to collect data to support regulatory clearance by the FDA in the United States and to determine the functionality of the WallFlex™ Biliary Partially Covered Stent as a Palliative treatment for malignant bile duct obstruction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Inoperable extrahepatic biliary obstruction by any malignant process\n* Indicated for metal stent placement for palliative treatment of biliary stricture(s) produced by malignant neoplasms\n* Willing and able to comply with the study procedures and provide written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Participation in another invesitgational study within 90 days prior to date of patient consent.\n* Strictures that cannot be dialated enough to pass the delivery system\n* Perforation of any duct within the biliary tree\n* Presence of any esophageal or duodenal stent\n* Patients for whom endoscopic procedures are contraindicated\n* Patients with known senesitivity to any components of the stent or delivery system\n* Patients with active hepatitis'}, 'identificationModule': {'nctId': 'NCT00713427', 'briefTitle': 'Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'A Multi-Center, Single Arm, Prospective Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction', 'orgStudyIdInfo': {'id': 'ENDO-WALLFLEX-BIL-PALL-002'}, 'secondaryIdInfos': [{'id': 'E7020'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'WallFlex Stent', 'description': 'All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted.', 'interventionNames': ['Device: WallFlex™ Biliary Partially-Covered Stent']}], 'interventions': [{'name': 'WallFlex™ Biliary Partially-Covered Stent', 'type': 'DEVICE', 'description': 'Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent.', 'armGroupLabels': ['WallFlex Stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'ULB Erasme Hospital', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '69437', 'city': 'Lyon', 'state': 'Cedex 3', 'country': 'France', 'facility': 'Hopital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': 'D-40217', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'EVK Krankenhaus der Universitat Dusseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '500082', 'city': 'Hyderabaad', 'country': 'India', 'facility': 'Asian Institute of Gastroenterology'}, {'zip': '00168', 'city': 'Rome', 'country': 'Italy', 'facility': 'Università Cattolica del Sacro Cuore', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '1105', 'city': 'Amsterdam', 'state': 'AZ', 'country': 'Netherlands', 'facility': 'Academisch Medisch Centrum Universiteit van Amsterdam', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Robert Walsh, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Boston Scientific Corporation'}, {'name': 'Guido Costamagna, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università Cattolica del Sacro Cuore, Policlinico A. Gemelli'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}