Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT00448006
Status:
WITHDRAWN
Last Update Posted:
2018-07-10
First Post:
2007-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Feasibility Study of Allium's Biliary Stent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001733', 'term': 'Bites and Stings'}], 'ancestors': [{'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069322', 'term': 'Self Expandable Metallic Stents'}], 'ancestors': [{'id': 'D015607', 'term': 'Stents'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'lastUpdateSubmitDate': '2018-07-09', 'studyFirstSubmitDate': '2007-03-14', 'studyFirstSubmitQcDate': '2007-03-14', 'lastUpdatePostDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body temperature measurement, patient comfort analysis, sonographic measurements of the duct channels, abdominal X-ray imaging of the stent, and blood tests will be performed at 24 hours, 30 days, 3, 6, and 12 months following stent insertion.', 'timeFrame': 'up to 12 months follow up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['common', 'bile', 'duct', 'biliary', 'malignant', 'obstruction', 'stent'], 'conditions': ['Malignant Obstruction of the Common Bile Duct']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://eng.sheba.co.il/main/siteNew/index.php', 'label': 'The Chaim Sheba Medical Center at Tel Hashomer'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of the Allium Biliary Stent in malignant obstructions of the common bile duct.', 'detailedDescription': 'Biliary duct stenoses are caused by intrinsic malignant disease of the common bile duct or by compression or infiltration of malignancies of the abdominal organs, i.e. pancreas, liver, stomach, duodenum, etc, or by iatrogenic reasons such as endoscopic biliary stone manipulations, biliary anastomoses or biliary duct reimplantation. In these diseases, a stent can be placed in the biliary duct canal to "open it" and relieve the obstruction. The Allium Biliary Stent is to be inserted into the biliary duct to allow free flow of biliary fluid from the liver to the duodenum by supporting the obstructed area of the biliary duct lumen, keep it open, and prevent its re-obstruction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is 18 years or older\n* Patient has malignant obstructive jaundice\n* Patient is unfit for surgery\n* Patient is capable of giving informed consent\n* Patient is willing to comply with study requirements\n\nExclusion Criteria:\n\n* Patient has a benign biliary duct obstruction\n* Patient cannot tolerate any form of antibiotic treatment\n* Patient is currently receiving anticoagulation therapy\n* Patient has history of illness, medication, or surgery that may affect the efficacy of the stent (e.g.: a previous surgical change in the anatomy of the common bile duct)'}, 'identificationModule': {'nctId': 'NCT00448006', 'briefTitle': "Clinical Feasibility Study of Allium's Biliary Stent", 'organization': {'class': 'INDUSTRY', 'fullName': 'Allium, Ltd.'}, 'officialTitle': 'A Clinical Feasibility Study to Evaluate the New Allium Biliary Stent, in Patients Suffering From "Malignant Biliary Duct Obstruction" (Endoscopic Insertion)', 'orgStudyIdInfo': {'id': 'BIS-CL-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Allium Biliary Stent', 'type': 'DEVICE', 'description': 'device'}, {'name': 'allium biliary stent', 'type': 'DEVICE', 'otherNames': ['self expandable stent'], 'description': 'allium biliary stent'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'overallOfficials': [{'name': 'Simon Bar-Meir, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allium, Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}