Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-29 @ 11:27 PM
Study NCT ID:
NCT01839292
Status:
COMPLETED
Last Update Posted:
2013-04-24
First Post:
2013-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ComVi and D-type Stent in Malignant GOO
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017219', 'term': 'Gastric Outlet Obstruction'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'lastUpdateSubmitDate': '2013-04-22', 'studyFirstSubmitDate': '2013-04-18', 'studyFirstSubmitQcDate': '2013-04-22', 'lastUpdatePostDateStruct': {'date': '2013-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the stent patency time from stent insertion to restenosis due to stent malfunction or death', 'timeFrame': 'Up to 1 years'}], 'secondaryOutcomes': [{'measure': 'stent malfunction (e.g., stent migration or occlusion due to tumor ingrowth/overgrowth) and the reintervention rate', 'timeFrame': 'up to 1 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['gastric outlet obstruction', 'palliative treatment', 'stent'], 'conditions': ['Gastric Outlet Obstruction']}, 'descriptionModule': {'briefSummary': 'Covered self-expandable metallic stents (SEMS) have been used to prevent tumor ingrowth, a common complication of uncovered SEMSs. However, they have revealed a high incidence of stent migration in patients with unresectable malignant gastric outlet obstruction (GOO). A conformable covered SEMS was introduced to overcome both stent migration and tumor ingrowth. The aims of this study were to evaluate the clinical outcomes of newly designed conformable covered and uncovered SEMS for palliation of malignant GOO.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults 18 years of age or older\n* obstructive symptoms due to unresectable malignant GOO\n* a Karnofsky performance score of more than 30 (13)\n\nExclusion Criteria:\n\n* history of a previous SEMS insertion\n* the presence of obstruction in the gastrointestinal tract excluding the gastric outlet\n* severe comorbidities precluding the endoscopic procedure, such as cardiopulmonary disease, sepsis, and bleeding disorders\n* a life expectancy of less than 1 month after SEMS insertion\n* history of gastric surgery'}, 'identificationModule': {'nctId': 'NCT01839292', 'briefTitle': 'ComVi and D-type Stent in Malignant GOO', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'A Newly Designed Conformable Uncovered Versus Covered Self-expandable Metallic Stent for Palliation of Malignant Gastric Outlet Obstruction: a Prospective, Randomized Multicenter Study', 'orgStudyIdInfo': {'id': 'AJIRB-DEV-DE4-10-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'uncovered D-type stent', 'description': 'uncovered D-type stent, which effectively reduces stent migration, especially in malignant colorectal obstruction', 'interventionNames': ['Device: uncovered D-type stent insertion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'double-layered ComVi stent', 'description': 'double-layered ComVi stent, which is a modified covered stent with an additional outer bare wire mesh to overcome both tumor ingrowth and stent migration', 'interventionNames': ['Device: double-layered ComVi stent insertion']}], 'interventions': [{'name': 'uncovered D-type stent insertion', 'type': 'DEVICE', 'armGroupLabels': ['uncovered D-type stent']}, {'name': 'double-layered ComVi stent insertion', 'type': 'DEVICE', 'armGroupLabels': ['double-layered ComVi stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '443-721', 'city': 'Suwon', 'country': 'South Korea', 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'Jin Hong Kim, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, {'name': 'Kyungpook National University Hospital', 'class': 'OTHER'}, {'name': 'Hallym University', 'class': 'OTHER'}, {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, {'name': 'Seoul National University', 'class': 'OTHER'}, {'name': 'DongGuk University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Sun Gyo Lim', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}