Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:08 AM
Study NCT ID:
NCT03434834
Status:
COMPLETED
Last Update Posted:
2021-04-06
First Post:
2018-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
OCT Pilot in Esophagus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001471', 'term': 'Barrett Esophagus'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'a.wax@duke.edu', 'phone': '919-660-5143', 'title': 'Dr. Adam Wax', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 week', 'description': 'Subjects were contacted 1 week after OCT imaging to assess any adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'OCT of Esophagus', 'description': 'All participants who were able to swallow the OCT probe had optical coherence tomography (OCT) imaging of the esophagus, with measurements in at least 5 locations.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 8, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea / vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'epigastric pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'esophageal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OCT of Esophagus', 'description': 'All participants who were able to swallow the OCT probe had optical coherence tomography (OCT) imaging of the esophagus, with measurements in at least 5 locations.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at baseline', 'description': 'Percentage of imaged sites correctly categorized by OCT as squamous mucosa when compared to endoscopy.', 'unitOfMeasure': 'percentage of imaged sites', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study.'}, {'type': 'PRIMARY', 'title': "Percentage of Imaged Sites Correctly Categorized as Barrett's Mucosa", 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OCT of Esophagus', 'description': 'All participants who were able to swallow the OCT probe had optical coherence tomography (OCT) imaging of the esophagus, with measurements in at least 5 locations.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at baseline', 'description': "Percentage of images site correctly categorized by OCT as Barrett's mucosa when compared to endoscopy.", 'unitOfMeasure': 'percentage of imaged sites', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Imaged Sites With Adequate Tissue Contact to Acquire a High Quality Image', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OCT of Esophagus', 'description': 'All participants who were able to swallow the OCT probe had optical coherence tomography (OCT) imaging of the esophagus, with measurements in at least 5 locations.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at baseline', 'description': 'Percentage of imaged sites that achieved adequate tissue contact to acquire high quality OCT images.', 'unitOfMeasure': 'percentage of imaged sites', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OCT of Esophagus', 'description': 'All participants who were able to swallow the OCT probe had optical coherence tomography (OCT) imaging of the esophagus, with measurements in at least 5 locations.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'unable to swallow OCT probe', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'OCT of Esophagus', 'description': 'All participants who were able to swallow the OCT probe had optical coherence tomography (OCT) imaging of the esophagus, with measurements in at least 5 locations.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.3', 'spread': '11.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '48', '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': '53', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "Stage of Barrett's Esophagus", 'classes': [{'categories': [{'title': "non-dysplastic Barrett's Esophagus", 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': "Barrett's Esophagus with low grade dysplasia", 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': "Barrett's Esophagus with high grade dysplasia", 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-09', 'size': 274975, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-10-01T12:18', 'hasProtocol': False}, {'date': '2020-04-14', 'size': 1364371, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-02-10T15:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-12', 'studyFirstSubmitDate': '2018-01-29', 'resultsFirstSubmitDate': '2021-02-19', 'studyFirstSubmitQcDate': '2018-02-09', 'lastUpdatePostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-12', 'studyFirstPostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa', 'timeFrame': 'at baseline', 'description': 'Percentage of imaged sites correctly categorized by OCT as squamous mucosa when compared to endoscopy.'}, {'measure': "Percentage of Imaged Sites Correctly Categorized as Barrett's Mucosa", 'timeFrame': 'at baseline', 'description': "Percentage of images site correctly categorized by OCT as Barrett's mucosa when compared to endoscopy."}], 'secondaryOutcomes': [{'measure': 'Percentage of Imaged Sites With Adequate Tissue Contact to Acquire a High Quality Image', 'timeFrame': 'at baseline', 'description': 'Percentage of imaged sites that achieved adequate tissue contact to acquire high quality OCT images.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Barrett Esophagus']}, 'descriptionModule': {'briefSummary': "This is a pilot study to test a newly developed optical coherence tomography (OCT) device to determine 1) whether adequate tissue contact can be attained to acquire high quality images, and 2) to identify if these images can discern whether the imaged tissue is squamous or Barrett's Esophagus (BE) epithelium."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Presenting to University of North Carolina (UNC) for routine care upper endoscopy\n2. Meet one of the following criteria:\n\n 1. Presenting to UNC for upper endoscopy of GI conditions without esophageal symptomology for with no history of gastroesophageal reflux disease (GERD) or other esophageal condition affecting the epithelium (asymptomatic controls), OR,\n 2. History of dysplastic or non-dysplastic Barrett's Esophagus with prague criteria C1+ or M3+\n3. Aged 18 to 80\n4. Able to read, comprehend, and understand the informed consent document.\n\nExclusion Criteria:\n\n1. Prior esophageal surgery (uncomplicated nissen fundoplication OK)\n2. Pregnant women\n3. Unable to provide written informed consent"}, 'identificationModule': {'nctId': 'NCT03434834', 'briefTitle': 'OCT Pilot in Esophagus', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Advanced Angle-Resolved Low Coherence Interferometry (a/LCI) Systems for Improved Clinical Utility: An Optical Coherence Tomography (OCT) Pilot Study', 'orgStudyIdInfo': {'id': 'Pro00090173'}, 'secondaryIdInfos': [{'id': 'R01CA210544', 'link': 'https://reporter.nih.gov/quickSearch/R01CA210544', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OCT of esophagus', 'description': 'optical coherence tomography of esophagus', 'interventionNames': ['Device: optical coherence tomography']}], 'interventions': [{'name': 'optical coherence tomography', 'type': 'DEVICE', 'description': 'OCT measurements of 5 locations in the esophagus', 'armGroupLabels': ['OCT of esophagus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Adam Wax, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}