Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-01-02 @ 7:53 AM
Study NCT ID:
NCT02005393
Status:
COMPLETED
Last Update Posted:
2017-03-28
First Post:
2013-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Comparing Flexible Spectral-Imaging Color Enhancement (FICE) With Olympus Narrow Band Imaging (NBI)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ruzenoff@fujifilm.com', 'phone': '(203) 602-3664', 'title': 'Robert Uzenoff: Executive Director of Clinical Science', 'organization': 'FujiFilm Medical Systems USA'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "There were no AE's for this study, however an event would have been considered an AE from the time they started the procedure, until the patient life the hospital for the day.", 'description': "No AE's (or SAE's) reported.", 'eventGroups': [{'id': 'EG000', 'title': 'FICE Image Acquisition Followed by NBI Image Acquisition', 'description': "Images Captured with FICE Image Acquisition System, immediately followed by Image Acquisition with NBI\n\nFICE Image Acquisition System: Images Captured with FICE Device\n\nNo AE's", 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Image Quality Scores Using Likert Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FICE Image Acquisition Followed by NBI Image Acquisition', 'description': 'Images Captured with FICE Image Acquisition System, immediately followed by NBI Image Acquisition; always in that order.\n\nFICE Image Acquisition System: Images Captured with FICE Device'}], 'classes': [{'title': 'FICE 0', 'categories': [{'measurements': [{'value': '3.2', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'FICE 1', 'categories': [{'measurements': [{'value': '3.3', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'FICE 2', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'FICE 3', 'categories': [{'measurements': [{'value': '3.3', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'FICE 4', 'categories': [{'measurements': [{'value': '3.3', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'FICE 5', 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'FICE 6', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'FICE 7', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'FICE 8', 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'FICE 9', 'categories': [{'measurements': [{'value': '3.2', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'NBI', 'categories': [{'measurements': [{'value': '3.1', 'spread': '1.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'groupDescription': 'All 20 subjects enrolled in the study, including Subject 219 that was dropped from the Reader assessments due to corrupted images, were all rated as having similar white light images between the FICE and NBI procedures for each location used in the concurrence study. This assessment was intended to assure that no procedural sequence or visualization bias was introduced into the image acquisition process. The overall Reader mean (SD) for both FICE and NBI were equal to or greater than 3.0 (0.8).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Image settings were considered non-inferior if scores overlapped within 1 SD of mean.', 'otherAnalysisDescription': 'The results reported utilized the average Likert scores for each of the 3 readers, for each of the FICE settings (0-9), as compared to FICE. The overall Reader mean (SD) for both FICE and NBI were equal to or greater than 3.0 (0.8).The overall mean scores were comparable between FICE and NBI to provide acceptable diagnostic image visualization quality.'}], 'paramType': 'MEAN', 'timeFrame': 'One day', 'description': 'Likert score ratings of image quality for FICE and NBI images. Each FICE setting was compared to NBI, to determine which FICE settings were equivalent to NBI.\n\nLikert Scores:\n\n1. Not seen;\n2. poor but usable, characteristic features are detectable but details are not fully reproduced; features just visible;\n3. good; allows an adequate assessment, details of anatomical structures are visible but not necessarily clearly defined; details emerging;\n4. very good; allows an excellent assesssment, anatomical details are clearly defined; details clear', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients had imaging done with both FICE, immediately followed by NBI. Images for one subject were not included in the Reader Study due to an error on the Compact Flash card which resulted in three (3) corrupt FICE images (FICE settings 0, 1 \\& 2); therefore making 19 out of 20 participants analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FICE Image Acquisition Followed by NBI Image Acquisition', 'description': 'Images Captured with FICE Image Acquisition immediately followed by NBI Image Acquisition\n\nFICE Image Acquisition System: Images Captured with FICE Device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Twenty subjects were recruited at Mayo Clinic, Scottsdale between 23Oct2013 and 08Nov2013 to have two endoscopies completed - one using Fujifilm's endoscope and processor equipped with FICE, and the second immediately following with Olympus' endoscope and processor equipped with NBI."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'FICE Image Acquisition Followed by NBI Image Acquisition', 'description': 'Images Captured with FICE Image Acquisition System immediately followed by Image Acquisition with NBI\n\nFICE Image Acquisition System: Images Captured with FICE Device'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-08', 'studyFirstSubmitDate': '2013-11-26', 'resultsFirstSubmitDate': '2015-08-17', 'studyFirstSubmitQcDate': '2013-12-04', 'lastUpdatePostDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-08', 'studyFirstPostDateStruct': {'date': '2013-12-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Image Quality Scores Using Likert Scale', 'timeFrame': 'One day', 'description': 'Likert score ratings of image quality for FICE and NBI images. Each FICE setting was compared to NBI, to determine which FICE settings were equivalent to NBI.\n\nLikert Scores:\n\n1. Not seen;\n2. poor but usable, characteristic features are detectable but details are not fully reproduced; features just visible;\n3. good; allows an adequate assessment, details of anatomical structures are visible but not necessarily clearly defined; details emerging;\n4. very good; allows an excellent assesssment, anatomical details are clearly defined; details clear'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['FICE', 'NBI'], 'conditions': ['Routine Endoscopy']}, 'descriptionModule': {'briefSummary': 'The study is intended to test the image quality of the FICE system to the predicate device, Narrow Band Imaging (NBI). The hypothesis is the images are of equal quality.', 'detailedDescription': 'No additional description required.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Referred for diagnostic endoscopy or colonoscopy\n* Ability to comply and willingness to partake in study\n\nExclusion Criteria:\n\n* less than 21 years of age\n* is an inmate'}, 'identificationModule': {'nctId': 'NCT02005393', 'acronym': 'FICE', 'briefTitle': 'Study Comparing Flexible Spectral-Imaging Color Enhancement (FICE) With Olympus Narrow Band Imaging (NBI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fujifilm Medical Systems USA, Inc.'}, 'officialTitle': 'A Concurrence Study of Diagnostic Visualization Comparing Flexible Spectral-Imaging Color Enhancement (FICE) With Olympus Narrow Band Imaging (NBI)', 'orgStudyIdInfo': {'id': 'P-13-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'FICE Imaging System followed by NBI', 'description': 'Images Captured with FICE Image Acquisition System (experimental) followed by NBI Image Acquisition System (standard of care); always in that order. Imaging took place in esophagus, gastric, duodenum and/or colon.', 'interventionNames': ['Device: FICE Image Acquisition followed by NBI Image Acquisition']}], 'interventions': [{'name': 'FICE Image Acquisition followed by NBI Image Acquisition', 'type': 'DEVICE', 'description': 'Images Captured with FICE Device, followed by same locations imaged with NBI Image Acquisition System', 'armGroupLabels': ['FICE Imaging System followed by NBI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic, Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'overallOfficials': [{'name': 'Mary Moore', 'role': 'STUDY_DIRECTOR', 'affiliation': 'FujiFilm Medical Systems USA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujifilm Medical Systems USA, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}