Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-04-24 @ 3:40 AM
Study NCT ID:
NCT02156505
Status:
UNKNOWN
Last Update Posted:
2014-06-05
First Post:
2014-06-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome Study of Double Bare Stent for Malignant Gastric Outlet Obstruction
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 49}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-06-04', 'studyFirstSubmitDate': '2014-06-02', 'studyFirstSubmitQcDate': '2014-06-04', 'lastUpdatePostDateStruct': {'date': '2014-06-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The patency rate at 8 weeks after placement.', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Technical and clinical success rates', 'timeFrame': 'up to 8 weeks'}, {'measure': 're-stenosis rate', 'timeFrame': '8 weeks'}, {'measure': 'migration rate', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stent', 'gastric outlet obstruction', 'restenosis'], 'conditions': ['Gastric Outlet Obstruction Due to Malignancy']}, 'descriptionModule': {'briefSummary': 'Self-expandable metallic stents provide effective palliation of malignant gastric outlet obstruction. However, uncovered stent are often associated with re-stenosis caused by tumor in-growth through the stent mesh. The Self-expandable metallic stents which has the design of smaller wire mesh size (double bare stent) were developed and used in Korea. This new design was developed to minimize the re-stenosis of uncovered stent, but the outcome is unknown. The end point of this study is the 8-weeks patency rate after placement of double bare as well as technical and clinical success rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Malignant gastric outlet obstruction\n* Symptoms compatible with gastric outlet obstruction\n* An inoperable condition because of extent of disease or patient's conditions\n\nExclusion Criteria:\n\n* History of enteral stent placement, undergone gastric surgery.\n* Additional small bowel stenosis distal to gastric outlet obstruction.\n* Refuse to be enrolled to study."}, 'identificationModule': {'nctId': 'NCT02156505', 'briefTitle': 'Outcome Study of Double Bare Stent for Malignant Gastric Outlet Obstruction', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Center, Korea'}, 'officialTitle': 'Phase IV Study of Double Bare Self-expandable Metallic Stent for Malignant Gastric Outlet Obstruction', 'orgStudyIdInfo': {'id': 'NCCCTSMD12009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DoubleBare stent', 'description': 'Placement of double bare stent', 'interventionNames': ['Procedure: placement of double bare stent', 'Device: DoubleBare stent']}], 'interventions': [{'name': 'placement of double bare stent', 'type': 'PROCEDURE', 'armGroupLabels': ['DoubleBare stent']}, {'name': 'DoubleBare stent', 'type': 'DEVICE', 'armGroupLabels': ['DoubleBare stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410-769', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Chan G Kim, M.D.', 'role': 'CONTACT', 'email': 'glse@chol.com', 'phone': '+82-31-920-1620'}, {'name': 'Chan G Kim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Cancer Center', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}], 'centralContacts': [{'name': 'Chan G Kim, M.D.', 'role': 'CONTACT', 'email': 'glse@chol.com', 'phone': '+82-31-920-1620'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Stent research group, Korean Society of Gastrointestinal Endoscopy, Korea', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior scientist', 'investigatorFullName': 'Chan Gyoo Kim', 'investigatorAffiliation': 'National Cancer Center, Korea'}}}}