Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-04-13 @ 12:39 AM
Study NCT ID:
NCT02020603
Status:
COMPLETED
Last Update Posted:
2016-01-21
First Post:
2013-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Hemostasis by Soft Coagulation Using Endoscopic Hemostatic Forceps for Acute Peptic Ulcer Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010438', 'term': 'Peptic Ulcer Hemorrhage'}], 'ancestors': [{'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057908', 'term': 'Argon Plasma Coagulation'}], 'ancestors': [{'id': 'D004564', 'term': 'Electrocoagulation'}, {'id': 'D002425', 'term': 'Cautery'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006489', 'term': 'Hemostatic Techniques'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D006488', 'term': 'Hemostasis, Surgical'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-20', 'studyFirstSubmitDate': '2013-12-15', 'studyFirstSubmitQcDate': '2013-12-19', 'lastUpdatePostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of bleeding within four weeks after initial hemostasis', 'timeFrame': 'up to 24 months'}], 'secondaryOutcomes': [{'measure': 'initial hemostasis rate', 'timeFrame': 'up to 24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['peptic ulcer bleeding', 'hemostatic forceps', 'soft coagulation', 'argon plasma coagulation'], 'conditions': ['Active Peptic Ulcer Disease/GI Bleeding']}, 'referencesModule': {'references': [{'pmid': '25730283', 'type': 'DERIVED', 'citation': 'Kim JW, Jang JY, Lee CK, Shim JJ, Chang YW. Comparison of hemostatic forceps with soft coagulation versus argon plasma coagulation for bleeding peptic ulcer--a randomized trial. Endoscopy. 2015 Aug;47(8):680-7. doi: 10.1055/s-0034-1391565. Epub 2015 Mar 2.'}]}, 'descriptionModule': {'briefSummary': 'Endoscopic high-frequency soft coagulation is available for the management of bleeding or nonbleeding visible vessels during endoscopic submucosal dissection. However, its efficacy on peptic ulcer bleeding has not been elucidated so far. The aim of this study was to evaluate the efficacy of hemostasis with soft coagulation using hemostatic forceps by comparing it with argon plasma coagulation (APC) in a prospective, randomized trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age greater than 18 years\n* peptic ulcer with stigmata of recent hemorrhage\n\nExclusion Criteria:\n\n* malignant ulcer\n* previous gastric surgery'}, 'identificationModule': {'nctId': 'NCT02020603', 'briefTitle': 'Efficacy of Hemostasis by Soft Coagulation Using Endoscopic Hemostatic Forceps for Acute Peptic Ulcer Bleeding', 'organization': {'class': 'OTHER', 'fullName': 'Kyunghee University Medical Center'}, 'officialTitle': 'Efficacy of Hemostasis by Soft Coagulation Using Endoscopic Hemostatic Forceps in Comparison With Argon Plasma Coagulation for Acute Peptic Ulcer Bleeding', 'orgStudyIdInfo': {'id': 'GUB2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'APC group', 'description': 'epinephrine injection plus argon plasma coagulation', 'interventionNames': ['Device: epinephrine injection plus argon plasma coagulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Forceps group', 'description': 'epinephrine injection plus soft coagulation using hemostatic forceps', 'interventionNames': ['Device: epinephrine injection plus soft coagulation using hemostatic forceps']}], 'interventions': [{'name': 'epinephrine injection plus soft coagulation using hemostatic forceps', 'type': 'DEVICE', 'armGroupLabels': ['Forceps group']}, {'name': 'epinephrine injection plus argon plasma coagulation', 'type': 'DEVICE', 'armGroupLabels': ['APC group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130-872', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jae Young Jang, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Kyung Hee University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyunghee University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical fellow', 'investigatorFullName': 'Jung-Wook Kim', 'investigatorAffiliation': 'Kyunghee University Medical Center'}}}}