Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-01-24 @ 6:09 AM
Study NCT ID:
NCT01962168
Status:
COMPLETED
Last Update Posted:
2015-04-08
First Post:
2013-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evolution® Biliary Stent System Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-07', 'studyFirstSubmitDate': '2013-10-09', 'studyFirstSubmitQcDate': '2013-10-11', 'lastUpdatePostDateStruct': {'date': '2015-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from symptomatic recurrent biliary obstruction requiring reintervention', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Technical success', 'timeFrame': 'Immediately following completion of the stent placement procedure', 'description': 'Technical success is defined as a stent successfully delivered and placed at its intended location at the end of the procedure.'}, {'measure': 'Incidence of device-related adverse events', 'timeFrame': '6 months'}, {'measure': 'Ease of use', 'timeFrame': 'Immediately following completion of the stent placement procedure', 'description': 'Ease of use will be evaluated on a five point scale ranging from very easy to very difficult.'}]}, 'conditionsModule': {'keywords': ['Biliary Tract Neoplasms', 'Neoplasms', 'Gastrointestinal Diseases', 'Digestive System Diseases', 'Biliary Tract', 'Stents'], 'conditions': ['Biliary Tract Neoplasms', 'Neoplasms', 'Gastrointestinal Diseases', 'Digestive System Diseases', 'Biliary Tract', 'Stents']}, 'referencesModule': {'references': [{'pmid': '32522161', 'type': 'DERIVED', 'citation': 'Lawrence C, Nieto J, Parsons WG, Roy A, Guda NM, Steinberg SE, Hasan MK, Bucobo JC, Nagula S, Dey ND, Buscaglia JM; Study Investigators. A newly designed uncovered biliary stent for palliation of malignant obstruction: results of a prospective study. BMC Gastroenterol. 2020 Jun 10;20(1):184. doi: 10.1186/s12876-020-01325-9.'}]}, 'descriptionModule': {'briefSummary': 'The Evolution® Biliary Stent System Clinical Study is a clinical trial on a commercially available device to gather physician experience with the Cook Evolution® Biliary Stent System for the palliation of cancer in the biliary tree. Patients will be treated as per usual medical practices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Candidates for biliary stent placement based on institutional guidelines and product IFU.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is considered a candidate for stent placement based on institutional guidelines and product IFU.\n\nExclusion Criteria:\n\n* Patient is less than 18 years of age.\n* Patient is unable or unwilling to provide written informed consent.\n* Patient is unable or unwilling to comply with the follow-up schedule.'}, 'identificationModule': {'nctId': 'NCT01962168', 'briefTitle': 'Evolution® Biliary Stent System Clinical Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cook Group Incorporated'}, 'officialTitle': 'Palliation of Biliary Neoplasms With the Cook Evolution® Biliary Stent System', 'orgStudyIdInfo': {'id': '12-009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Evolution® Biliary Stent - Uncovered', 'interventionNames': ['Device: Evolution® Biliary Stent - Uncovered']}], 'interventions': [{'name': 'Evolution® Biliary Stent - Uncovered', 'type': 'DEVICE', 'description': 'Commercially available device', 'armGroupLabels': ['Evolution® Biliary Stent - Uncovered']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36607', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Mobile Infirmary Medical Center', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'The Pancreas and Biliary Center of South Florida', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Borland-Groover Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '60005', 'city': 'Arlington Heights', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwest Community Hospital', 'geoPoint': {'lat': 42.08836, 'lon': -87.98063}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY at Stony Brook Hospital', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Aurora Saint Luke's Medical Center", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'H2X 3J4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre Hospitalier de l' Universite de Montreal (CHUM)", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Christopher Lawrence', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Summerville GI & Advanced Endoscopy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cook Group Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}