Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-16 @ 11:27 AM
Study NCT ID:
NCT01952418
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2013-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Video Monitor Size on Adenoma Detection Rate
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'NNISHIOKA@PARTNERS.ORG', 'phone': '6177264422', 'title': 'Norman Nishioka, MD', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Standard Monitor (24")', 'description': 'Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24").', 'otherNumAtRisk': 910, 'otherNumAffected': 0, 'seriousNumAtRisk': 910, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Large Monitor (32")', 'description': 'Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32").', 'otherNumAtRisk': 895, 'otherNumAffected': 0, 'seriousNumAtRisk': 895, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adenoma Detection Rate (All Indications)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '910', 'groupId': 'OG000'}, {'value': '895', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Monitor (24")', 'description': 'Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24").'}, {'id': 'OG001', 'title': 'Large Monitor (32")', 'description': 'Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32").'}], 'classes': [{'categories': [{'measurements': [{'value': '264', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 2 weeks (range of 1 day-14 days) of the endoscopy', 'description': 'Number of patients with adenoma detected', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all indications'}, {'type': 'PRIMARY', 'title': 'Adenoma Detection Rate (Screening Exams Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '491', 'groupId': 'OG000'}, {'value': '522', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Monitor (24")', 'description': 'Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24").'}, {'id': 'OG001', 'title': 'Large Monitor (32")', 'description': 'Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32").'}], 'classes': [{'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 2 weeks (range of 1 day-14 days) of the endoscopy', 'description': 'Number of patients with adenoma detected', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'screening exams only'}, {'type': 'SECONDARY', 'title': 'Polyp Detection Rate (All Indications)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '910', 'groupId': 'OG000'}, {'value': '895', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Monitor (24")', 'description': 'Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24").'}, {'id': 'OG001', 'title': 'Large Monitor (32")', 'description': 'Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32").'}], 'classes': [{'categories': [{'measurements': [{'value': '367', 'groupId': 'OG000'}, {'value': '424', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'recorded during endoscopy (immediate)', 'description': 'Number of patients with polyps detected', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all indications'}, {'type': 'SECONDARY', 'title': 'Polyp Detection Rate (Screening Exams Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '491', 'groupId': 'OG000'}, {'value': '522', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Monitor (24")', 'description': 'Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24").'}, {'id': 'OG001', 'title': 'Large Monitor (32")', 'description': 'Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32").'}], 'classes': [{'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'recorded during endoscopy (immediate)', 'description': 'Number of patients with polyps detected', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'screening exams only'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Monitor (24")', 'description': 'Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24").'}, {'id': 'FG001', 'title': 'Large Monitor (32")', 'description': 'Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32").'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '910'}, {'groupId': 'FG001', 'numSubjects': '895'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '910'}, {'groupId': 'FG001', 'numSubjects': '895'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '910', 'groupId': 'BG000'}, {'value': '895', 'groupId': 'BG001'}, {'value': '1805', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Monitor (24")', 'description': 'Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24").'}, {'id': 'BG001', 'title': 'Large Monitor (32")', 'description': 'Endoscopists in this arm will perform colonoscopy using the large size video monitor (32").'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.9', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '55.8', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '55.3', 'spread': '11.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '521', 'groupId': 'BG000'}, {'value': '498', 'groupId': 'BG001'}, {'value': '1019', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '389', 'groupId': 'BG000'}, {'value': '397', 'groupId': 'BG001'}, {'value': '786', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '910', 'groupId': 'BG000'}, {'value': '895', 'groupId': 'BG001'}, {'value': '1805', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'patients who had endoscopy performed in the study'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': '15 endoscopists and 1805 patients on which procedures were performed were randomly assigned to each room.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1805}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-21', 'studyFirstSubmitDate': '2013-09-19', 'resultsFirstSubmitDate': '2017-03-03', 'studyFirstSubmitQcDate': '2013-09-27', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-03', 'studyFirstPostDateStruct': {'date': '2013-09-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adenoma Detection Rate (All Indications)', 'timeFrame': 'within 2 weeks (range of 1 day-14 days) of the endoscopy', 'description': 'Number of patients with adenoma detected'}, {'measure': 'Adenoma Detection Rate (Screening Exams Only)', 'timeFrame': 'within 2 weeks (range of 1 day-14 days) of the endoscopy', 'description': 'Number of patients with adenoma detected'}], 'secondaryOutcomes': [{'measure': 'Polyp Detection Rate (All Indications)', 'timeFrame': 'recorded during endoscopy (immediate)', 'description': 'Number of patients with polyps detected'}, {'measure': 'Polyp Detection Rate (Screening Exams Only)', 'timeFrame': 'recorded during endoscopy (immediate)', 'description': 'Number of patients with polyps detected'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colon Adenoma']}, 'referencesModule': {'references': [{'pmid': '30986402', 'type': 'DERIVED', 'citation': 'Jovani M, Campbell EJ, Hur C, Joshi AD, Nishioka NS. Effect of video monitor size on polyp detection: a prospective, randomized, controlled trial. Gastrointest Endosc. 2019 Aug;90(2):254-258.e2. doi: 10.1016/j.gie.2019.03.1172. Epub 2019 Apr 12.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to compare the adenoma detection rate achieved while using either a 24" video monitor or a 32" video monitor.', 'detailedDescription': 'Gastrointestinal endoscopists perfoming routine endoscopic procedures and their patients will be randomized to one of two endoscopy rooms at the MGH Ambulatory Endoscopy Center at Charles River Plaza. The two rooms will have identical equipment with the exception that one room will have the current standard size video monitor (NDS 26") used at this facility while the other room will have a larger video monitor (NDS 32"). The ADR achieved by each physician in each room will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physician endoscopist performing colonoscopy at Massachusetts General Hospital GI Endoscopy Unit\n* Patients receiving these procedures at Massachusetts General Hospital GI Endoscopy Unit\n\nExclusion Criteria:\n\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT01952418', 'briefTitle': 'Effect of Video Monitor Size on Adenoma Detection Rate', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Effect of Video Monitor Size on Adenoma Detection Rate', 'orgStudyIdInfo': {'id': '2013p001462'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard monitor (24")', 'description': 'Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24").'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Large monitor (32")', 'description': 'Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32").', 'interventionNames': ['Device: Monitor size']}], 'interventions': [{'name': 'Monitor size', 'type': 'DEVICE', 'description': 'Subjects will be randomized to perform their colonoscopy procedures while viewing a large (32") video monitor or the standard (24") video monitor.', 'armGroupLabels': ['Large monitor (32")']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Norman S Nishioka, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Norman Nishioka, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}