Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-27 @ 9:15 PM
Study NCT ID:
NCT00583466
Status:
COMPLETED
Last Update Posted:
2017-09-13
First Post:
2007-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Blood as a Submucosal Cushion During Endoscopic Polypectomy and Mucosal Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'registerclinicaltrials@jhmi.edu', 'phone': '410-550-6484', 'title': 'Johns Hopkins ClinicalTrials.gov Program', 'organization': 'Johns Hopkins University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'There is no adverse event data available for this record. The PI has left the institution and has been contacted. Per the PI the data is no longer available and the study has not been published.', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': 'Polypectomy with normal saline injected for submucosal cushion creation Normal saline: Normal saline will be injected under the lesion to create submucosal cushion\n\nOR\n\nPolypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion HPMC: Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion\n\nOR\n\nPolypectomy after injection of autologous blood Autologous blood injection: Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Duration of the Submucosal Cushion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1 Normal Saline Arm', 'description': 'Polypectomy with normal saline injected for submucosal cushion creation\n\nNormal saline: Normal saline will be injected under the lesion to create submucosal cushion'}, {'id': 'OG001', 'title': '2 HPMC Arm', 'description': 'Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion\n\nHPMC: Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion'}, {'id': 'OG002', 'title': '3 Blood Arm', 'description': 'Polypectomy after injection of autologous blood\n\nAutologous blood injection: Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion'}], 'timeFrame': 'Immediately after the procedure, Up to 5 minutes', 'reportingStatus': 'POSTED', 'populationDescription': 'No data is available for this record. The PI has left the institution and has been contacted. Per the PI the data is no longer available and the study has not been published.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'Polypectomy with normal saline injected for submucosal cushion creation Normal saline: Normal saline will be injected under the lesion to create submucosal cushion\n\nOR\n\nPolypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion HPMC: Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion\n\nOR\n\nPolypectomy after injection of autologous blood Autologous blood injection: Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'No data on how participants were randomized, and no further baseline data (other than categorical age and sex) are available for this record. The PI has left the institution and has been contacted. Per the PI the data are no longer available and the study has not been published.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Polypectomy with normal saline injected for submucosal cushion creation Normal saline: Normal saline will be injected under the lesion to create submucosal cushion\n\nOR\n\nPolypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion HPMC: Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion\n\nOR\n\nPolypectomy after injection of autologous blood Autologous blood injection: Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '>= 18, <= 90', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'No data on how participants were randomized, and no further baseline data (other than categorical age and sex) are available for this record. The PI has left the institution and has been contacted. Per the PI the data are no longer available and the study has not been published.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-11', 'studyFirstSubmitDate': '2007-12-20', 'resultsFirstSubmitDate': '2017-08-11', 'studyFirstSubmitQcDate': '2007-12-20', 'lastUpdatePostDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-09-11', 'studyFirstPostDateStruct': {'date': '2007-12-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of the Submucosal Cushion', 'timeFrame': 'Immediately after the procedure, Up to 5 minutes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['submucosal cushion', 'polypectomy', 'endoscopic mucosal resection'], 'conditions': ['Large Polyps in the Gastrointestinal Tract']}, 'referencesModule': {'references': [{'pmid': '17163324', 'type': 'BACKGROUND', 'citation': 'Giday SA, Magno P, Buscaglia JM, Canto MI, Ko CW, Shin EJ, Xia L, Wroblewski LM, Clarke JO, Kalloo AN, Jagannath SB, Kantsevoy SV. Is blood the ideal submucosal cushioning agent? A comparative study in a porcine model. Endoscopy. 2006 Dec;38(12):1230-4. doi: 10.1055/s-2006-944971.'}]}, 'descriptionModule': {'briefSummary': 'For removal of large flat lesions of the gastro-intestinal tract injection of a solution under the lesion creates a "safety" cushion and protects from damage to the gastrointestinal tract wall. Various solutions are currently used, but some of them are easy to inject but quickly dissipate (normal saline),other solutions are more longer lasting (hydroxypropyl methylcellulose, hyaluronic acid, etc) but are very difficult to inject and can be expensive and not always available. The investigators performed previously animal experiments which demonstrated that blood is easy to inject and creates a protective cushion which lasts longer than other fluids which are currently used for protective cushion creation.', 'detailedDescription': 'For removal of large flat lesions of the gastro-intestinal tract injection of a solution under the lesion creates a "safety" cushion and protects from damage to the gastrointestinal tract wall. Various solutions are currently used, but some of them are easy to inject but quickly dissipate (normal saline),other solutions are more longer lasting (hydroxypropyl methylcellulose, hyaluronic acid, etc) but are very difficult to inject and can be expensive and not always available. The investigators decided to use blood drawn from the patient for injection under the lesion. The investigators performed previously animal experiments which demonstrated that blood is easy to inject and creates a protective cushion which lasts longer than other fluids which are currently used for protective cushion creation. Blood can also have local hemostatic action preventing from bleeding during polypectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Polyps equal or larger than 1 cm\n\nExclusion Criteria:\n\n* Coagulopathy\n* Inability to sign informed consent'}, 'identificationModule': {'nctId': 'NCT00583466', 'briefTitle': 'Evaluation of Blood as a Submucosal Cushion During Endoscopic Polypectomy and Mucosal Resection', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Evaluation of Blood as a Submucosal Cushion During Endoscopic Polypectomy and Mucosal Resection', 'orgStudyIdInfo': {'id': 'NA_00008376'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1 Normal saline arm', 'description': 'Polypectomy with normal saline injected for submucosal cushion creation', 'interventionNames': ['Drug: Normal saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 HPMC arm', 'description': 'Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion', 'interventionNames': ['Drug: HPMC']}, {'type': 'EXPERIMENTAL', 'label': '3 Blood arm', 'description': 'Polypectomy after injection of autologous blood', 'interventionNames': ['Drug: Autologous blood injection']}], 'interventions': [{'name': 'Autologous blood injection', 'type': 'DRUG', 'description': 'Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion', 'armGroupLabels': ['3 Blood arm']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': 'Normal saline will be injected under the lesion to create submucosal cushion', 'armGroupLabels': ['1 Normal saline arm']}, {'name': 'HPMC', 'type': 'DRUG', 'description': 'Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion', 'armGroupLabels': ['2 HPMC arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Sergey V. Kantsevoy, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}