Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-02-26 @ 5:46 PM
Study NCT ID:
NCT04086433
Status:
COMPLETED
Last Update Posted:
2020-06-25
First Post:
2019-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gastric Tissue Stapler Comparison Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alison@regulatorymark.com', 'phone': '5133047971', 'title': 'Alison Sathe', 'organization': 'Regulatory Mark'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Not applicable. Investigation performed on excised tissue.', 'description': 'Not applicable. Investigation performed on excised tissue.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A - Echelon Stapler', 'description': 'Excised gastric tissue specimens will be resected with the Echelon Stapler (Ethicon, size: 60mm, "Echelon") and evaluated for burst pressure and staple malformation\n\ngastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm B - Titan Stapler', 'description': 'Excised gastric tissue specimens will be resected with the Titan SGS Stapler (Standard Bariatrics, "Titan") and evaluated for burst pressure and staple malformation\n\ngastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Other', 'notes': 'All-cause mortality, serious and other adverse events were not monitored assessed. These are not applicable to this study because the study was performed on previously excised tissue.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pressure Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Echelon Stapler', 'description': 'Excised gastric tissue specimens will be resected with the Echelon Stapler (Ethicon, size: 60mm, "Echelon") and evaluated for burst pressure and staple malformation\n\ngastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment'}, {'id': 'OG001', 'title': 'Arm B - Titan Stapler', 'description': 'Excised gastric tissue specimens will be resected with the Titan SGS Stapler (Standard Bariatrics, "Titan") and evaluated for burst pressure and staple malformation\n\ngastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment'}], 'classes': [{'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '226'}, {'value': '163', 'groupId': 'OG001', 'lowerLimit': '82', 'upperLimit': '259'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'immediately post operative', 'description': 'Burst pressure will be assessed in the specimen with one staple line (i.e. the test staple line) with a pressure volume curve recorded.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Staple Malformation', 'timeFrame': 'through study completion, anticipate within 2 months', 'description': 'Staple line specimen will be sent to an independent laboratory for imaging. Percentage of malformed staples in test staple line will be recorded by an independent assessor.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A - Echelon Stapler', 'description': 'Excised gastric tissue specimens will be resected with the Echelon Stapler (Ethicon, size: 60mm, "Echelon") and evaluated for burst pressure and staple malformation\n\ngastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment'}, {'id': 'FG001', 'title': 'Arm B - Titan Stapler', 'description': 'Excised gastric tissue specimens will be resected with the Titan SGS Stapler (Standard Bariatrics, "Titan") and evaluated for burst pressure and staple malformation\n\ngastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A - Echelon Stapler', 'description': 'Excised gastric tissue specimens will be resected with the Echelon Stapler (Ethicon, size: 60mm, "Echelon") and evaluated for burst pressure and staple malformation\n\ngastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment'}, {'id': 'BG001', 'title': 'Arm B - Titan Stapler', 'description': 'Excised gastric tissue specimens will be resected with the Titan SGS Stapler (Standard Bariatrics, "Titan") and evaluated for burst pressure and staple malformation\n\ngastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000', 'lowerLimit': '28', 'upperLimit': '57'}, {'value': '46', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '66'}, {'value': '44', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '66'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2019-06-17', 'size': 228091, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-05-21T17:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-10', 'studyFirstSubmitDate': '2019-07-29', 'resultsFirstSubmitDate': '2020-05-21', 'studyFirstSubmitQcDate': '2019-09-09', 'lastUpdatePostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-21', 'studyFirstPostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pressure Evaluation', 'timeFrame': 'immediately post operative', 'description': 'Burst pressure will be assessed in the specimen with one staple line (i.e. the test staple line) with a pressure volume curve recorded.'}, {'measure': 'Staple Malformation', 'timeFrame': 'through study completion, anticipate within 2 months', 'description': 'Staple line specimen will be sent to an independent laboratory for imaging. Percentage of malformed staples in test staple line will be recorded by an independent assessor.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Gastric Resection']}, 'descriptionModule': {'briefSummary': 'This study is conducted to compare performance characteristics of staple lines resecting the stomach in excised human gastric tissue with existing Echelon Flex Powered Plus GST System (Ethicon, size: 60mm, "Echelon") stapler and the Titan SGS (Standard Bariatrics, "Titan").\n\nThe Study is a single center clinical trial, randomized (1:1, Arm A - Ethicon Echelon 60 application, Arm B - Standard Bariatrics Titan SGS application) which utilizes the excised stomach tissue from up to 75 adults undergoing laparoscopic sleeve gastrectomy (LSG). This study will be conducted in the USA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects undergoing Laparoscopic Sleeve Gastrectomy', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Laparoscopic sleeve gastrectomy patients at study site, ages 18 to 80\n\nExclusion Criteria:\n\n1. Prior gastric surgery (lap band, Nissen fundoplication, G tube, greater curve plication, etc.)\n2. Gastric lesion recognized during surgery (entire specimen would be sent to pathology)\n3. Stomach damaged during extraction'}, 'identificationModule': {'nctId': 'NCT04086433', 'briefTitle': 'Gastric Tissue Stapler Comparison Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Standard Bariatrics'}, 'officialTitle': 'Gastric Tissue Stapler Comparison Study', 'orgStudyIdInfo': {'id': 'CP-2018-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm A - Echelon Stapler', 'description': 'Excised gastric tissue specimens will be resected with the Echelon Stapler (Ethicon, size: 60mm, "Echelon") and evaluated for burst pressure and staple malformation', 'interventionNames': ['Device: gastric tissue resection']}, {'label': 'Arm B - Titan Stapler', 'description': 'Excised gastric tissue specimens will be resected with the Titan SGS Stapler (Standard Bariatrics, "Titan") and evaluated for burst pressure and staple malformation', 'interventionNames': ['Device: gastric tissue resection']}], 'interventions': [{'name': 'gastric tissue resection', 'type': 'DEVICE', 'description': 'human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment', 'armGroupLabels': ['Arm A - Echelon Stapler', 'Arm B - Titan Stapler']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'University at Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Aaron B Hoffman, MD, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University at Buffalo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Standard Bariatrics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}