Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT01288612
Status:
COMPLETED
Last Update Posted:
2015-01-07
First Post:
2011-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparative Effectiveness of Endoscopic Assessment of Gastroesophageal Reflux and Barretts Esophagus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'iyer.prasad@mayo.edu', 'phone': '507-284-6469', 'title': 'Prasad G. Iyer', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '30 days after the procedure', 'description': 'All participants received a telephone call from the research coordinator 1 and 30 days after the procedure to complete adverse events questionnaires.', 'eventGroups': [{'id': 'EG000', 'title': 'Sedated Endoscopy', 'description': 'Sedated esophagogastroduodenoscopy with biopsy\n\nSedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.', 'otherNumAtRisk': 61, 'otherNumAffected': 14, 'seriousNumAtRisk': 61, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Transnasal Endoscopy at Hospital Unit', 'description': 'Unsedated transnasal endoscopy at hospital unit.\n\nTransnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.', 'otherNumAtRisk': 69, 'otherNumAffected': 20, 'seriousNumAtRisk': 69, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Transnasal Endoscopy at Mobile Unit', 'description': 'Unsedated transnasal endoscopy in mobile research van\n\nTransnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.', 'otherNumAtRisk': 76, 'otherNumAffected': 23, 'seriousNumAtRisk': 76, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Sore Throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epitaxis', 'notes': 'Self-limiting nose bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal/chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Who Agreed to Participated in the Esophageal Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '158', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedated Endoscopy', 'description': 'Sedated esophagogastroduodenoscopy with biopsy\n\nSedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.'}, {'id': 'OG001', 'title': 'Transnasal Endoscopy at Hospital Unit', 'description': 'Unsedated transnasal endoscopy at hospital unit.\n\nTransnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.'}, {'id': 'OG002', 'title': 'Transnasal Endoscopy at Mobile Unit', 'description': 'Unsedated transnasal endoscopy in mobile research van\n\nTransnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.7', 'groupId': 'OG000'}, {'value': '45.7', 'groupId': 'OG001'}, {'value': '47.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.42', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.27', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.82', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately 2 weeks after invitation letter was sent', 'description': 'This outcome measure was defined as the proportion of subjects who agreed to undergo esophageal assessment in the three groups out of those who were eligible to be contacted for participation in screening.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population for this outcome measure was the number of subjects per group who were eligible to contact.'}, {'type': 'SECONDARY', 'title': 'Rate of Successful Intubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedated Endoscopy', 'description': 'Sedated esophagogastroduodenoscopy with biopsy\n\nSedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.'}, {'id': 'OG001', 'title': 'Transnasal Endoscopy at Hospital Unit', 'description': 'Unsedated transnasal endoscopy at hospital unit.\n\nTransnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.'}, {'id': 'OG002', 'title': 'Transnasal Endoscopy at Mobile Unit', 'description': 'Unsedated transnasal endoscopy in mobile research van\n\nTransnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '95.8', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 1', 'description': 'The rate of successful intubation was defined as the ability to traverse the upper esophageal sphincter and visualize the esophageal mucosa and classified as successful or unsuccessful.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).'}, {'type': 'SECONDARY', 'title': 'Rate of Complete Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedated Endoscopy', 'description': 'Sedated esophagogastroduodenoscopy with biopsy\n\nSedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.'}, {'id': 'OG001', 'title': 'Transnasal Endoscopy at Hospital Unit', 'description': 'Unsedated transnasal endoscopy at hospital unit.\n\nTransnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.'}, {'id': 'OG002', 'title': 'Transnasal Endoscopy at Mobile Unit', 'description': 'Unsedated transnasal endoscopy in mobile research van\n\nTransnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.'}], 'classes': [{'title': 'Complete', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}]}, {'title': 'Incomplete', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Unsuccessful', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 1', 'description': 'The rate of complete evaluation was defined as visualization of the whole esophagus and identification of landmarks: squamocolumnar junction, gastroesophageal junction (upper margin of gastric folds with stomach deflated), and the diaphragmatic hiatus. The categories of evaluation were classified as complete (all three landmarks identified), incomplete (some landmarks identified), or unsuccessful.', 'unitOfMeasure': 'procedures', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).'}, {'type': 'SECONDARY', 'title': 'Rate of Acquisition of Biopsies From the Esophagus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedated Endoscopy', 'description': 'Sedated esophagogastroduodenoscopy with biopsy\n\nSedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.'}, {'id': 'OG001', 'title': 'Transnasal Endoscopy at Hospital Unit', 'description': 'Unsedated transnasal endoscopy at hospital unit.\n\nTransnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.'}, {'id': 'OG002', 'title': 'Transnasal Endoscopy at Mobile Unit', 'description': 'Unsedated transnasal endoscopy in mobile research van\n\nTransnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.'}], 'classes': [{'title': 'Successful', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '83.3', 'groupId': 'OG001'}, {'value': '79.0', 'groupId': 'OG002'}]}]}, {'title': 'Unsuccessful', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 1', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).'}, {'type': 'SECONDARY', 'title': 'Mean Duration of Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedated Endoscopy', 'description': 'Sedated esophagogastroduodenoscopy with biopsy\n\nSedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.'}, {'id': 'OG001', 'title': 'Transnasal Endoscopy at Hospital Unit', 'description': 'Unsedated transnasal endoscopy at hospital unit.\n\nTransnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.'}, {'id': 'OG002', 'title': 'Transnasal Endoscopy at Mobile Unit', 'description': 'Unsedated transnasal endoscopy in mobile research van\n\nTransnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '2.7', 'groupId': 'OG001'}, {'value': '8.5', 'spread': '2.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Visit 1', 'description': 'Duration of the procedure was defined as time from the beginning of the procedure (initiation of sedation or local anesthesia) to extubation.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).'}, {'type': 'SECONDARY', 'title': 'Mean Time From Extubation to Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedated Endoscopy', 'description': 'Sedated esophagogastroduodenoscopy with biopsy\n\nSedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.'}, {'id': 'OG001', 'title': 'Transnasal Endoscopy at Hospital Unit', 'description': 'Unsedated transnasal endoscopy at hospital unit.\n\nTransnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.'}, {'id': 'OG002', 'title': 'Transnasal Endoscopy at Mobile Unit', 'description': 'Unsedated transnasal endoscopy in mobile research van\n\nTransnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.3', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '18.5', 'spread': '4.2', 'groupId': 'OG001'}, {'value': '15.5', 'spread': '2.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Visit 1', 'description': 'This outcome measures the recovery time after the procedure.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).'}, {'type': 'SECONDARY', 'title': 'Mean Tolerability Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedated Endoscopy', 'description': 'Sedated esophagogastroduodenoscopy with biopsy\n\nSedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.'}, {'id': 'OG001', 'title': 'Transnasal Endoscopy at Hospital Unit', 'description': 'Unsedated transnasal endoscopy at hospital unit.\n\nTransnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.'}, {'id': 'OG002', 'title': 'Transnasal Endoscopy at Mobile Unit', 'description': 'Unsedated transnasal endoscopy in mobile research van\n\nTransnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.'}], 'classes': [{'title': 'Pain', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '8.8', 'groupId': 'OG002'}]}]}, {'title': 'Choking', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '1.9', 'groupId': 'OG002'}]}]}, {'title': 'Gagging', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '2.3', 'groupId': 'OG002'}]}]}, {'title': 'Anxiety', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '2.8', 'groupId': 'OG002'}]}]}, {'title': 'Overall Tolerance', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '2.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison between the arms for pain scale', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison between the arms for choking scale', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison between the arms for gagging scale', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison between the arms for anxiety scale', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison between arms for overall tolerance scale', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 after the procedure', 'description': 'Validated pain scales (where 0 is none and 10 is severe) were used to assess the degree of pain, choking, gagging, and anxiety experienced during the procedure. Overall tolerance was rated on a scale from 0 to 10, where 0 is good, and 10 is poor tolerance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).'}, {'type': 'SECONDARY', 'title': 'Acceptability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedated Endoscopy', 'description': 'Sedated esophagogastroduodenoscopy with biopsy\n\nSedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.'}, {'id': 'OG001', 'title': 'Transnasal Endoscopy at Hospital Unit', 'description': 'Unsedated transnasal endoscopy at hospital unit.\n\nTransnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.'}, {'id': 'OG002', 'title': 'Transnasal Endoscopy at Mobile Unit', 'description': 'Unsedated transnasal endoscopy in mobile research van\n\nTransnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.'}], 'classes': [{'title': 'Acceptable', 'categories': [{'measurements': [{'value': '93.4', 'groupId': 'OG000'}, {'value': '83.3', 'groupId': 'OG001'}, {'value': '78.9', 'groupId': 'OG002'}]}]}, {'title': 'Unacceptable', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '21.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 after the procedure', 'description': 'Acceptability was defined as the proportion of subjects willing to undergo the procedure again in the future.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sedated Endoscopy', 'description': 'Sedated esophagogastroduodenoscopy with biopsy\n\nSedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.'}, {'id': 'FG001', 'title': 'Transnasal Endoscopy at Hospital Unit', 'description': 'Unsedated transnasal endoscopy at hospital unit.\n\nTransnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.'}, {'id': 'FG002', 'title': 'Transnasal Endoscopy at Mobile Unit', 'description': 'Unsedated transnasal endoscopy in mobile research van\n\nTransnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '151'}, {'groupId': 'FG002', 'numSubjects': '158'}]}, {'type': 'Contacted', 'achievements': [{'groupId': 'FG000', 'numSubjects': '139'}, {'groupId': 'FG001', 'numSubjects': '135'}, {'groupId': 'FG002', 'numSubjects': '138'}]}, {'type': 'Agreed to Take Part', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '72'}, {'groupId': 'FG002', 'numSubjects': '76'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '69'}, {'groupId': 'FG002', 'numSubjects': '76'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '82'}, {'groupId': 'FG002', 'numSubjects': '82'}]}], 'dropWithdraws': [{'type': 'Unable to contact', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'Declined', 'reasons': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '62'}]}, {'type': 'Unable to intubate', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Eligible participants were identified using the Rochester Epidemiology Project resources from Olmsted County, Minnesota residents. The study took place between 1 April 2011 and 30 October 2013.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}, {'value': '459', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Sedated Endoscopy', 'description': 'Sedated esophagogastroduodenoscopy with biopsy\n\nSedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.'}, {'id': 'BG001', 'title': 'Transnasal Endoscopy at Hospital Unit', 'description': 'Unsedated transnasal endoscopy at hospital unit.\n\nTransnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.'}, {'id': 'BG002', 'title': 'Transnasal Endoscopy at Mobile Unit', 'description': 'Unsedated transnasal endoscopy in mobile research van\n\nTransnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '9', 'groupId': 'BG000'}, {'value': '64', 'spread': '10', 'groupId': 'BG001'}, {'value': '64', 'spread': '10', 'groupId': 'BG002'}, {'value': '65', 'spread': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '250', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '209', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}, {'value': '459', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Reflux Symptoms', 'classes': [{'title': 'Heartburn or acid regurgitation > 1/week', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}]}, {'title': 'Heartburn or acid regurgitation < 1/week', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '197', 'groupId': 'BG003'}]}]}, {'title': 'No heartburn or acid regurgitation', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '219', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education', 'classes': [{'title': 'Less than high school', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'High school or some college', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '225', 'groupId': 'BG003'}]}]}, {'title': 'College/professional training', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}]}, {'title': 'Unknown/not answered', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Employment', 'classes': [{'title': 'Employed', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '167', 'groupId': 'BG003'}]}]}, {'title': 'Unemployed/homemaker', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}, {'title': 'Retired', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '248', 'groupId': 'BG003'}]}]}, {'title': 'Unknown/not answered', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Marital Status', 'classes': [{'title': 'Married', 'categories': [{'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '349', 'groupId': 'BG003'}]}]}, {'title': 'Not married (single/widowed/divorced/separated)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}]}, {'title': 'Unknown/not answered', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Use of Proton Pump Inhibitor (PPI)', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}, {'value': '383', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 459}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-23', 'studyFirstSubmitDate': '2011-01-28', 'resultsFirstSubmitDate': '2014-12-23', 'studyFirstSubmitQcDate': '2011-02-01', 'lastUpdatePostDateStruct': {'date': '2015-01-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-23', 'studyFirstPostDateStruct': {'date': '2011-02-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects Who Agreed to Participated in the Esophageal Assessment', 'timeFrame': 'Approximately 2 weeks after invitation letter was sent', 'description': 'This outcome measure was defined as the proportion of subjects who agreed to undergo esophageal assessment in the three groups out of those who were eligible to be contacted for participation in screening.'}], 'secondaryOutcomes': [{'measure': 'Rate of Successful Intubation', 'timeFrame': 'Visit 1', 'description': 'The rate of successful intubation was defined as the ability to traverse the upper esophageal sphincter and visualize the esophageal mucosa and classified as successful or unsuccessful.'}, {'measure': 'Rate of Complete Evaluation', 'timeFrame': 'Visit 1', 'description': 'The rate of complete evaluation was defined as visualization of the whole esophagus and identification of landmarks: squamocolumnar junction, gastroesophageal junction (upper margin of gastric folds with stomach deflated), and the diaphragmatic hiatus. The categories of evaluation were classified as complete (all three landmarks identified), incomplete (some landmarks identified), or unsuccessful.'}, {'measure': 'Rate of Acquisition of Biopsies From the Esophagus', 'timeFrame': 'Visit 1'}, {'measure': 'Mean Duration of Procedure', 'timeFrame': 'Visit 1', 'description': 'Duration of the procedure was defined as time from the beginning of the procedure (initiation of sedation or local anesthesia) to extubation.'}, {'measure': 'Mean Time From Extubation to Discharge', 'timeFrame': 'Visit 1', 'description': 'This outcome measures the recovery time after the procedure.'}, {'measure': 'Mean Tolerability Scores', 'timeFrame': 'Day 1 after the procedure', 'description': 'Validated pain scales (where 0 is none and 10 is severe) were used to assess the degree of pain, choking, gagging, and anxiety experienced during the procedure. Overall tolerance was rated on a scale from 0 to 10, where 0 is good, and 10 is poor tolerance.'}, {'measure': 'Acceptability', 'timeFrame': 'Day 1 after the procedure', 'description': 'Acceptability was defined as the proportion of subjects willing to undergo the procedure again in the future.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Barrett's Esophagus"], 'conditions': ["Barrett's Esophagus"]}, 'referencesModule': {'references': [{'pmid': '25488897', 'type': 'RESULT', 'citation': "Sami SS, Dunagan KT, Johnson ML, Schleck CD, Shah ND, Zinsmeister AR, Wongkeesong LM, Wang KK, Katzka DA, Ragunath K, Iyer PG. A randomized comparative effectiveness trial of novel endoscopic techniques and approaches for Barrett's esophagus screening in the community. Am J Gastroenterol. 2015 Jan;110(1):148-58. doi: 10.1038/ajg.2014.362. Epub 2014 Dec 9."}]}, 'descriptionModule': {'briefSummary': 'The hypothesis of this study was that the comparative effectiveness of unsedated transnasal endoscopy (uTNE) will be greater than sedated endoscopy (sEGD) in population screening for BE.', 'detailedDescription': "Barrett's esophagus (BE), a well-known complication of Gastroesophageal Reflux (GER), is the strongest known precursor of esophageal adenocarcinoma. Thus, identifying effective screening approaches for the early detection of BE are highly desired. Current impediments to BE screening include 1) the inability to utilize sedated endoscopy (sEGD) effectively in populations and 2) current GER-based paradigms for detecting BE. Referral center studies demonstrate comparable accuracy between unsedated transnasal endoscopy (uTNE) and sEGD. However, patient acceptability and diagnostic yield with uTNE in general populations remain unknown.\n\nUsing the Rochester, Minnesota Epidemiology Project resources, random samples of Olmsted County residents were drawn, and those subjects were mailed validated gastrointestinal symptom questionnaires. These surveys allowed identification of a cohort of community subjects well characterized by the frequency of reflux symptoms. Eligible subjects who were greater than or equal to 50 years old, and who had no previous history of endoscopic evaluation and who were not known to have BE were randomized, stratified by age, sex, and reflux symptoms, and assigned to one of the 3 arms of the study. Subjects in each arm who met the eligibility criteria were initially sent generic invitation letters asking if they agreed to be contacted by phone in two weeks' time to inform them about a research study. If potential subjects explicitly declined to be contacted they were excluded from the study. Eligible subjects were contacted by telephone and only offered the endoscopy technique they had been randomized to. Subjects who accepted and signed an informed consent document were treated according to their randomized assignment and all 3 groups were followed up in the same manner.\n\nBiopsies were taken from any endoscopically suspected BE and from the gastroesophageal junction and squamous mucosa in all subjects. The length of BE segment was defined using Prague criteria. All participants received a telephone call from the research coordinator 1 and 30 days after the procedure to complete validated tolerability scales and adverse events questionnaires."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Olmsted county, Minnesota resident\n* Age 50 or older\n* Able to give informed consent\n\nExclusion Criteria:\n\n* History of known Barretts Esophagus (BE) or endoscopy within the last 10 years\n* History of progressive dysphagia\n* Known Zenkers or epiphrenic diverticulum\n* History of recurrent epistaxis\n* Illnesses that impair ability to complete questionnaires (e.g. metastatic cancer, stroke, dementia)\n* Contraindication to esophageal biopsy (such as anticoagulation using warfarin or clopidogrel).'}, 'identificationModule': {'nctId': 'NCT01288612', 'acronym': 'challenge', 'briefTitle': 'Comparative Effectiveness of Endoscopic Assessment of Gastroesophageal Reflux and Barretts Esophagus', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Comparative Effectiveness of Endoscopic Assessment of Gastroesophageal Reflux and Barretts Esophagus', 'orgStudyIdInfo': {'id': '10-007787'}, 'secondaryIdInfos': [{'id': 'RC4DK090413', 'link': 'https://reporter.nih.gov/quickSearch/RC4DK090413', 'type': 'NIH'}, {'id': 'UL1TR000135', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR000135', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sedated Endoscopy', 'description': 'Sedated esophagogastroduodenoscopy with biopsy', 'interventionNames': ['Device: Sedated Endoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transnasal Endoscopy at Hospital Unit', 'description': 'Unsedated transnasal endoscopy at hospital unit.', 'interventionNames': ['Device: Transnasal Endoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transnasal Endoscopy at Mobile Unit', 'description': 'Unsedated transnasal endoscopy in mobile research van', 'interventionNames': ['Device: Transnasal Endoscopy']}], 'interventions': [{'name': 'Sedated Endoscopy', 'type': 'DEVICE', 'description': 'The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.', 'armGroupLabels': ['Sedated Endoscopy']}, {'name': 'Transnasal Endoscopy', 'type': 'DEVICE', 'description': 'Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.', 'armGroupLabels': ['Transnasal Endoscopy at Hospital Unit', 'Transnasal Endoscopy at Mobile Unit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Prasad G. Iyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}, {'name': 'American College of Gastroenterology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Prasad G. Iyer', 'investigatorAffiliation': 'Mayo Clinic'}}}}