Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-01-24 @ 6:47 PM
Study NCT ID:
NCT02054260
Status:
UNKNOWN
Last Update Posted:
2014-11-19
First Post:
2014-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgicel® (Fibrillar) in Non-variceal UGI Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C013695', 'term': 'Surgicel'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'lastUpdateSubmitDate': '2014-11-18', 'studyFirstSubmitDate': '2014-02-03', 'studyFirstSubmitQcDate': '2014-02-03', 'lastUpdatePostDateStruct': {'date': '2014-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rebleeding rate at the second look endoscopy', 'timeFrame': '2 year'}]}, 'conditionsModule': {'conditions': ['Non-variceal Upper Gastrointestinal Bleeding']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess of effect of Surgicel® (Fibrillar) for preventing delayed bleeding after endoscopic hemostasis in non-variceal upper gastrointestinal bleeding'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with non variceal upper gastrointestinal bleeding proven by esophagogastroduodenoscopy\n* Patients with active bleeding (Forrest classification Ia or Ib or IIa)\n\nExclusion Criteria:\n\n* Patients with upper gastrointestinal tract malignancy\n* Patients with acute severe illness\n* Coagulopathy: liver cirrhosis, thrombocytopenia\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT02054260', 'briefTitle': 'Surgicel® (Fibrillar) in Non-variceal UGI Bleeding', 'organization': {'class': 'OTHER', 'fullName': 'Soonchunhyang University Hospital'}, 'orgStudyIdInfo': {'id': 'SCHBC_IRB_2013-40'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surgicel add therapy', 'interventionNames': ['Drug: Surgicel']}], 'interventions': [{'name': 'Surgicel', 'type': 'DRUG', 'armGroupLabels': ['Surgicel add therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '420-767', 'city': 'Bucheon-si', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Su Jin Hong, MD, PhD', 'role': 'CONTACT', 'email': 'sjhong@schmc.ac.kr', 'phone': '+82-32-621-5087'}], 'facility': 'Digestive Disease Center and Research Institute, Department of Internal Medicine, Soonchunhyang University College of Medicine', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}], 'centralContacts': [{'name': 'Su Jin Hong, MD, PhD', 'role': 'CONTACT', 'email': 'sjhong@schmc.ac.kr', 'phone': '+82-32-621-5087'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soonchunhyang University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Su Jin Hong', 'investigatorAffiliation': 'Soonchunhyang University Hospital'}}}}