Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-03-03 @ 6:26 AM
Study NCT ID:
NCT02066233
Status:
COMPLETED
Last Update Posted:
2017-07-06
First Post:
2014-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prospective Study to Compare the Efficacy of E.G.Scan to Detect Barrett's Esophagus Compared With Standard Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001471', 'term': 'Barrett Esophagus'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D006356', 'term': 'Heartburn'}], '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'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Iyer.Prasad@mayo.edu', 'phone': '507-284-6469', 'title': 'Dr. Prasad G. Iyer', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 weeks', 'description': 'Presenting adverse events per per intervention was not possible, as most patients were sedated prior to the procedures and only a few were not sedated. Therefore the adverse events were per patient population (study arm).', 'eventGroups': [{'id': 'EG000', 'title': "Subjects With Barrett's Esophagus", 'description': 'All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 44, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Subjects With Reflux and/or Heartburn', 'description': 'All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 44, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Gagging/Retching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 32, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 36, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Choking', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 38, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 43, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 34, 'numAffected': 34}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nose Bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Median Tolerability Score on 10-point Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Subjects With Barrett's Esophagus", 'description': 'All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.'}, {'id': 'OG001', 'title': 'Subjects With Reflux and/or Heartburn', 'description': 'All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.'}], 'classes': [{'title': 'EG II Scan', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '10'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '10'}]}]}, {'title': 'Standard Endoscopy', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '10'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 48 hours', 'description': 'On the 10-point VAS, 0 represented the "worst experience" and 10 the "best experience."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Subjects With Barrett's Esophagus", 'description': 'All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.'}, {'id': 'OG001', 'title': 'Subjects With Reflux and/or Heartburn', 'description': 'All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.'}], 'classes': [{'title': 'Nasal Camera Test', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Oral Camera Test', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Either Test', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Two weeks', 'description': 'Subjects were asked the following question: "Based on the overall experience (including need for sedation, ability to drive, time off work, procedure comfort, procedure time, etc.). Which procedure would you prefer to have in the future?" Possible answers were: Nasal camera test (EG), oral camera test (Gastroscopy), or either test.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Two subjects on the reflux and/or heartburn arm didn't answer this question."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': "Subjects With Barrett's Esophagus", 'description': 'All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.'}, {'id': 'FG001', 'title': 'Subjects With Reflux and/or Heartburn', 'description': 'All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.'}], 'periods': [{'title': 'EG Scan II (Day 1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'difficulty intubating subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}, {'title': 'Standard Endoscopy (Day 2)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': "Subjects With Barrett's Esophagus", 'description': 'All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.'}, {'id': 'BG001', 'title': 'Subjects With Reflux and/or Heartburn', 'description': 'All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.66', 'spread': '11.62', 'groupId': 'BG000'}, {'value': '51.72', 'spread': '15.07', 'groupId': 'BG001'}, {'value': '56.19', 'spread': '14.12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-06', 'studyFirstSubmitDate': '2014-02-03', 'resultsFirstSubmitDate': '2017-05-01', 'studyFirstSubmitQcDate': '2014-02-18', 'lastUpdatePostDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-06', 'studyFirstPostDateStruct': {'date': '2014-02-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median Tolerability Score on 10-point Visual Analog Scale (VAS)', 'timeFrame': 'Within 48 hours', 'description': 'On the 10-point VAS, 0 represented the "worst experience" and 10 the "best experience."'}], 'secondaryOutcomes': [{'measure': 'Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy', 'timeFrame': 'Two weeks', 'description': 'Subjects were asked the following question: "Based on the overall experience (including need for sedation, ability to drive, time off work, procedure comfort, procedure time, etc.). Which procedure would you prefer to have in the future?" Possible answers were: Nasal camera test (EG), oral camera test (Gastroscopy), or either test.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ["Barrett's", 'esophagus', 'reflux', 'heartburn', 'screening'], 'conditions': ["Barrett's Esophagus"]}, 'referencesModule': {'references': [{'pmid': '30081223', 'type': 'DERIVED', 'citation': "Sami SS, Iyer PG, Pophali P, Halland M, di Pietro M, Ortiz-Fernandez-Sordo J, White JR, Johnson M, Guha IN, Fitzgerald RC, Ragunath K. Acceptability, Accuracy, and Safety of Disposable Transnasal Capsule Endoscopy for Barrett's Esophagus Screening. Clin Gastroenterol Hepatol. 2019 Mar;17(4):638-646.e1. doi: 10.1016/j.cgh.2018.07.019. Epub 2018 Aug 3."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate whether a disposable nasal endoscope called "E.G. Scan II" will visualize the esophagus as well as the standard test, sedated endoscopy.', 'detailedDescription': 'All subjects underwent two procedures: the E.G.Scan II followed by standard endoscopy in a tandem design. The E.G. Scan II is a transnasal endoscope system to capture and transmit images of the esophagus. Captured images can be reviewed via the E.G. View for diagnosis of diseases related to the esophagus. Generally, the commercial esophagoscope system has reusable probes, but E.G. Scan™ II has a single use probe because reusable probes have the risk of infection and pollution.\n\nPrior to the E.G.Scan, subjects received a standard prep for the procedure. The two procedures were performed by two different experienced endoscopists who were blinded to the indication of the procedure. At both procedures a note was made of any abnormality of the esophagus. Every subject with an endoscopic diagnosis of Barrett\'s Esophagus had clinical biopsies taken to confirm diagnosis. Subject tolerability was measured with a 10-point visual analog scale (VAS) where 0 represented the "worst experience" and 10 the "best experience."'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adult participants aged 18 years or above who are scheduled for routine upper GI endoscopy for Barrett's Esophagus surveillance, varices surveillance and dyspepsia.\n2. Able and willing to give informed consent.\n\nExclusion Criteria:\n\n1. Patients known to be intolerant to endoscopy.\n2. Patients with frequent epistaxis.\n3. Patients not clinically fit for endoscopy as judged by their care team.\n4. Pregnant women.\n5. Patients with allergy/sensitivity to Simethicone (Mylicon), Phenylephrine, Lidocaine nasal spray, Benzocaine spray (Topex)\n6. Use of anticoagulants or antiplatelets."}, 'identificationModule': {'nctId': 'NCT02066233', 'briefTitle': "Prospective Study to Compare the Efficacy of E.G.Scan to Detect Barrett's Esophagus Compared With Standard Endoscopy", 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': "Prospective Study to Compare the Efficacy of E.G.Scan to Detect Barrett's Esophagus Compared With Standard Endoscopy", 'orgStudyIdInfo': {'id': '13-008214'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': "Subjects with Barrett's Esophagus", 'description': 'All subjects will receive transnasal endoscopy (EG Scan II) followed by standard endoscopy.', 'interventionNames': ['Device: EG Scan II (transnasal endoscopy)', 'Procedure: Standard Endoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Subjects with Reflux and/or Heartburn', 'description': 'All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.', 'interventionNames': ['Device: EG Scan II (transnasal endoscopy)', 'Procedure: Standard Endoscopy']}], 'interventions': [{'name': 'EG Scan II (transnasal endoscopy)', 'type': 'DEVICE', 'armGroupLabels': ["Subjects with Barrett's Esophagus", 'Subjects with Reflux and/or Heartburn']}, {'name': 'Standard Endoscopy', 'type': 'PROCEDURE', 'armGroupLabels': ["Subjects with Barrett's Esophagus", 'Subjects with Reflux and/or Heartburn']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Prasad G Iyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'IntroMedic Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Prasad G. Iyer', 'investigatorAffiliation': 'Mayo Clinic'}}}}