Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT04239118
Status:
COMPLETED
Last Update Posted:
2020-01-23
First Post:
2020-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
New Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014456', 'term': 'Ulcer'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010976', 'term': 'Platelet Count'}], 'ancestors': [{'id': 'D001772', 'term': 'Blood Cell Count'}, {'id': 'D002452', 'term': 'Cell Count'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D010979', 'term': 'Platelet Function Tests'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002468', 'term': 'Cell Physiological Phenomena'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-19', 'studyFirstSubmitDate': '2020-01-19', 'studyFirstSubmitQcDate': '2020-01-19', 'lastUpdatePostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the timing of final hemostasis', 'timeFrame': 'a week', 'description': 'the timing of final hemostasis'}], 'secondaryOutcomes': [{'measure': 'the frequency of recurrent bleeding', 'timeFrame': '1 year', 'description': 'the frequency of recurrent bleeding'}, {'measure': 'mortality rates', 'timeFrame': '1 year', 'description': 'mortality rates'}, {'measure': 'healing of ulcerative defects', 'timeFrame': '1 year', 'description': 'sizes of ulcerative defects'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ulcer', 'bleeding', 'treatment', 'aseptisorb-A'], 'conditions': ['Ulcer Hemorrhage']}, 'descriptionModule': {'briefSummary': 'The purpose of the study was to improve treatment results of patients with bleeding gastroduodenal ulcers by endoscopic applications of autoplasma, enriched with platelets and granular sorbent aseptisorb-A.', 'detailedDescription': 'The clinical study was conducted on the basis of the Voronezh city specialized Center for the treatment of patients with gastrointestinal bleeding. The study included 112 patients with ulcerative gastroduodenal bleeding. All patients were divided into two groups by random sampling: the main group (n=57 people) and the comparison group (n=55 people). In the treatment of patients of the main group (57 people), an individual approach was used with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets, in the complex endoscopic treatment of bleeding-complicated gastroduodenal ulcers (Patent Russian Federation (RF) № 2632771). In the comparison group (55 people), traditional methods of endoscopic hemostasis were used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '67 Years', 'minimumAge': '44 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gastroduodenal ulcers with bleeding\n\nExclusion Criteria:\n\n* Bleedings of other etiology'}, 'identificationModule': {'nctId': 'NCT04239118', 'briefTitle': 'New Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers', 'organization': {'class': 'OTHER', 'fullName': 'Voronezh N.N. Burdenko State Medical Academy'}, 'officialTitle': 'New Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers', 'orgStudyIdInfo': {'id': 'Cherednikov'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Applications of autoplasma, enriched with platelets and', 'description': 'Endoscopic applications of autoplasma, enriched with platelets and granular sorbent aseptisorb-A in bleeding gastroduodenal ulcers', 'interventionNames': ['Combination Product: Complex endoscopic treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets']}, {'type': 'OTHER', 'label': 'Traditional methods of endoscopic hemostasis', 'description': 'Traditional methods of endoscopic hemostasis were used without the use of platelet-enriched plasma and granular sorbents.', 'interventionNames': ['Procedure: Traditional methods of endoscopic hemostasis']}], 'interventions': [{'name': 'Complex endoscopic treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets', 'type': 'COMBINATION_PRODUCT', 'description': 'Complex endoscopic bleeding ulcers treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets', 'armGroupLabels': ['Applications of autoplasma, enriched with platelets and']}, {'name': 'Traditional methods of endoscopic hemostasis', 'type': 'PROCEDURE', 'description': 'Traditional methods of endoscopic hemostasis were used without the use of platelet-enriched plasma and granular sorbents', 'armGroupLabels': ['Traditional methods of endoscopic hemostasis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '394019', 'city': 'Voronezh', 'country': 'Russia', 'facility': 'Voronezh State Medical University', 'geoPoint': {'lat': 51.66833, 'lon': 39.19204}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Voronezh N.N. Burdenko State Medical Academy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}