Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 3:47 AM
Study NCT ID:
NCT04718493
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2021-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Stenting in Crohn Related Strictures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2020-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-27', 'studyFirstSubmitDate': '2021-01-18', 'studyFirstSubmitQcDate': '2021-01-18', 'lastUpdatePostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical success rate', 'timeFrame': 'Peroperative'}, {'measure': 'Adverse event rate', 'timeFrame': 'Within 7 days'}], 'secondaryOutcomes': [{'measure': 'Clinical success rate', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intestinal Strictures Related to Crohn´s Disease']}, 'referencesModule': {'references': [{'pmid': '33722805', 'type': 'DERIVED', 'citation': 'Hedenstrom P, Stotzer PO. Endoscopic treatment of Crohn-related strictures with a self-expandable stent compared with balloon dilation: a prospective, randomised, controlled study. BMJ Open Gastroenterol. 2021 Mar;8(1):e000612. doi: 10.1136/bmjgast-2021-000612.'}]}, 'descriptionModule': {'briefSummary': 'Prospective, randomized-controlled trial comparing self-expandable metal stent versus ballon dialtation only for the endoscopic treatment of benign strictures related to Crohn´s disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Benign high-grade Crohn stricture\n\nExclusion Criteria:\n\n* Unwillingness to participate\n* Planned surgery\n* High risk for bleeding'}, 'identificationModule': {'nctId': 'NCT04718493', 'briefTitle': 'Endoscopic Stenting in Crohn Related Strictures', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'Endoscopic Stenting in Crohn Related Strictures', 'orgStudyIdInfo': {'id': 'Project database VGR 95381'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stent', 'interventionNames': ['Procedure: Self-expandable metal stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dilatation', 'interventionNames': ['Procedure: Balloon dilatation']}], 'interventions': [{'name': 'Self-expandable metal stent', 'type': 'PROCEDURE', 'description': 'Endoscopic stenting of intestinal stricture related to Crohn´s disease', 'armGroupLabels': ['Stent']}, {'name': 'Balloon dilatation', 'type': 'PROCEDURE', 'description': 'Endoscopic balloon dilatation of intestinal stricture related to Crohn´s disease', 'armGroupLabels': ['Dilatation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Per-Ove Stotzer, Ass Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Per Hedenström', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}