Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-01 @ 2:10 AM
Study NCT ID:
NCT05275556
Status:
COMPLETED
Last Update Posted:
2025-01-14
First Post:
2022-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'splowman@verily.com', 'phone': '650-861-9783', 'title': 'Dr. Scooter Plowman', 'organization': 'Verily'}, 'certainAgreement': {'otherDetails': 'PIs may publish, but there are limitations to protect confidential information and/or allow the sponsor to publish first.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 day', 'description': 'An AE is defined as any untoward medical occurrence, unintended disease or injury in subjects, users or other persons, that is considered a change from baseline or pre-study status, whether or not related to the investigational medical device. Any pre-existing medical condition or symptoms present in a subject will not be considered an AE in this study, unless it worsens as a result of this study. For this study, AEs related to the study device and study procedures will be reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Colonoscopy (Standard of Care)', 'description': 'The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.', 'otherNumAtRisk': 694, 'deathsNumAtRisk': 694, 'otherNumAffected': 0, 'seriousNumAtRisk': 694, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'CADe Device', 'description': "The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.\n\nComputer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making.", 'otherNumAtRisk': 713, 'deathsNumAtRisk': 713, 'otherNumAffected': 0, 'seriousNumAtRisk': 713, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Difference in Adenomas Per Colonoscopy (APC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '694', 'groupId': 'OG000'}, {'value': '713', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colonoscopy (Standard of Care)', 'description': 'The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.'}, {'id': 'OG001', 'title': 'CADe Device', 'description': "The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.\n\nComputer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making."}], 'classes': [{'categories': [{'measurements': [{'value': '0.60', 'groupId': 'OG000', 'lowerLimit': '0.56', 'upperLimit': '0.64'}, {'value': '0.74', 'groupId': 'OG001', 'lowerLimit': '0.71', 'upperLimit': '0.77'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '0.07', 'ciUpperLimit': '0.23', 'pValueComment': 'Threshold for significance is 0.025.', 'statisticalMethod': 'Poisson Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1', 'description': 'Difference in Adenomas Per Colonoscopy (APC) between the control and intervention arm, evaluated for superiority. APC is defined as the average number of histologically confirmed adenomas resected per colonoscopy.', 'unitOfMeasure': 'Resected adenomas', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat'}, {'type': 'PRIMARY', 'title': 'Difference in Positive Percent Agreement (PPA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '694', 'groupId': 'OG000'}, {'value': '713', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colonoscopy (Standard of Care)', 'description': 'The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.'}, {'id': 'OG001', 'title': 'CADe Device', 'description': "The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.\n\nComputer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making."}], 'classes': [{'categories': [{'measurements': [{'value': '0.62', 'groupId': 'OG000', 'lowerLimit': '0.58', 'upperLimit': '0.66'}, {'value': '0.56', 'groupId': 'OG001', 'lowerLimit': '0.52', 'upperLimit': '0.60'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.03', 'pValueComment': 'Threshold for significance is 0.025.', 'statisticalMethod': 'Resampling based', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority margin is -10%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1', 'description': 'Difference in Positive Percent Agreement (PPA) between the control and intervention arm, evaluated for non-inferiority. PPA is defined as the total number of histologically confirmed Clinically Significant Excised Lesions, divided by the total number of excisions.', 'unitOfMeasure': 'Proportion of significant lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat'}, {'type': 'SECONDARY', 'title': 'Adenoma Detection Rate (ADR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '694', 'groupId': 'OG000'}, {'value': '713', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colonoscopy (Standard of Care)', 'description': 'The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.'}, {'id': 'OG001', 'title': 'CADe Device', 'description': "The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.\n\nComputer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making."}], 'classes': [{'categories': [{'measurements': [{'value': '38.9', 'groupId': 'OG000', 'lowerLimit': '35.3', 'upperLimit': '42.6'}, {'value': '42.9', 'groupId': 'OG001', 'lowerLimit': '39.2', 'upperLimit': '46.6'}]}]}], 'analyses': [{'pValue': '0.031', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.5', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '11.2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Threshold for significance is 0.025.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'The Adenoma Detection Rate is defined as the number of patients with at least one histologically confirmed adenoma divided by the total number of patients enrolled per study arm.', 'unitOfMeasure': 'Percentage of participants with adenomas', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat'}, {'type': 'SECONDARY', 'title': 'Number of False Alerts Per Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '713', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CADe Device', 'description': "The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.\n\nComputer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making."}], 'classes': [{'categories': [{'measurements': [{'value': '417', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'rate', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.58', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'A false alert is defined as a bounding box that persists on the screen (approximately 2-3 seconds per the judgment of the colonoscopist) that is then determined by the colonoscopist not to contain a polyp. The false alert rate is calculated as the number of false alerts per procedure conducted in the intervention arm of the study.', 'unitOfMeasure': 'Number of false alerts', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat'}, {'type': 'SECONDARY', 'title': 'Mean Withdrawal and Inspection Time (MWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '660', 'groupId': 'OG000'}, {'value': '669', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colonoscopy (Standard of Care)', 'description': 'The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.'}, {'id': 'OG001', 'title': 'CADe Device', 'description': "The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.\n\nComputer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making."}], 'classes': [{'categories': [{'measurements': [{'value': '8.97', 'spread': '4.97', 'groupId': 'OG000'}, {'value': '9.34', 'spread': '4.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.169', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.58', 'statisticalMethod': 'Permutation test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '2 sided test for differences between arms'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'The withdrawal time is defined as the time measured from the moment the withdrawal phase of the procedure begins (with the scope in the cecum) to the moment the scope is withdrawn from the patient. The Inspection time measurement will exclude washing and resection, and other peri-resection activity not deemed to be colonic inspection. Inspection times for both the control arm and intervention arm will be calculated retrospectively upon review of the video recordings.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Convenience sample of available videos'}, {'type': 'SECONDARY', 'title': 'Polyp Detection Rate (PDR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '694', 'groupId': 'OG000'}, {'value': '713', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colonoscopy (Standard of Care)', 'description': 'The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.'}, {'id': 'OG001', 'title': 'CADe Device', 'description': "The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.\n\nComputer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making."}], 'classes': [{'categories': [{'measurements': [{'value': '364', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Descriptive analysis: 52.4 in Colonoscopy (Standard of Care), 59.6 in CAD-e Device'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Polyp detection rate is defined as the proportion of patients with at least one histologically-confirmed polyp detected.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}, {'type': 'SECONDARY', 'title': 'Proximal Adenoma Detection Rate (pADR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '694', 'groupId': 'OG000'}, {'value': '713', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colonoscopy (Standard of Care)', 'description': 'The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.'}, {'id': 'OG001', 'title': 'CADe Device', 'description': "The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.\n\nComputer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making."}], 'classes': [{'categories': [{'measurements': [{'value': '198', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0578', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.6', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '9.4', 'pValueComment': 'Nominal p-value.', 'groupDescription': 'Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \\<= CADe Device percentage (i.e. test of superiority)', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'pADR is defined as the percentage of patients with at least one histologically-confirmed adenoma detected in proximal colon.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Flat Adenoma Detection Rate (fADR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '694', 'groupId': 'OG000'}, {'value': '713', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colonoscopy (Standard of Care)', 'description': 'The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.'}, {'id': 'OG001', 'title': 'CADe Device', 'description': "The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.\n\nComputer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making."}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7813', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '2.0', 'pValueComment': 'Nominal p-value', 'groupDescription': 'Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \\<= CADe Device percentage (i.e. test of superiority)', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'fADR is defined as the percentage of patients with at least one histologically-confirmed non-polypoid adenoma detected.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat'}, {'type': 'SECONDARY', 'title': 'Serrated Lesions Per Colonoscopy (SLPC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '694', 'groupId': 'OG000'}, {'value': '713', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colonoscopy (Standard of Care)', 'description': 'The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.'}, {'id': 'OG001', 'title': 'CADe Device', 'description': "The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.\n\nComputer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making."}], 'classes': [{'categories': [{'measurements': [{'value': '0.34', 'groupId': 'OG000', 'lowerLimit': '0.30', 'upperLimit': '0.38'}, {'value': '0.46', 'groupId': 'OG001', 'lowerLimit': '0.42', 'upperLimit': '0.50'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '0.05', 'ciUpperLimit': '0.17', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1', 'description': 'SLPC is defined as the number of histologically confirmed serrated lesions detected, divided by the total number of colonoscopies.', 'unitOfMeasure': 'serated lesions per colonoscopy', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat'}, {'type': 'SECONDARY', 'title': 'Serrated Lesions Detection Rate (SLDR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '694', 'groupId': 'OG000'}, {'value': '713', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colonoscopy (Standard of Care)', 'description': 'The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.'}, {'id': 'OG001', 'title': 'CADe Device', 'description': "The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.\n\nComputer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making."}], 'classes': [{'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.3', 'ciLowerLimit': '3.7', 'ciUpperLimit': '12.9', 'pValueComment': 'Nominal p-value', 'groupDescription': 'Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \\<= CADe Device percentage (i.e. test of superiority)', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'SLDR is defined as the percentage of patients with at least one histologically confirmed serrated lesion detected.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat'}, {'type': 'SECONDARY', 'title': 'Adenoma Detection Rate Including Carcinoma (ADR*)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '694', 'groupId': 'OG000'}, {'value': '713', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colonoscopy (Standard of Care)', 'description': 'The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.'}, {'id': 'OG001', 'title': 'CADe Device', 'description': "The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.\n\nComputer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making."}], 'classes': [{'categories': [{'measurements': [{'value': '271', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1185', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.1', 'ciLowerLimit': '-1', 'ciUpperLimit': '9.1', 'pValueComment': 'Nominal p-value', 'groupDescription': 'Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \\<= CADe Device percentage (i.e. test of superiority)', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'ADR\\* is defined as ADR, but also includes histologically-confirmed intramucosal carcinoma and adenocarcinoma.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat'}, {'type': 'SECONDARY', 'title': 'Small Adenoma Detection Rate (sADR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '694', 'groupId': 'OG000'}, {'value': '713', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colonoscopy (Standard of Care)', 'description': 'The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.'}, {'id': 'OG001', 'title': 'CADe Device', 'description': "The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.\n\nComputer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making."}], 'classes': [{'categories': [{'measurements': [{'value': '201', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0752', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.4', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '9.2', 'pValueComment': 'nominal p-value', 'groupDescription': 'Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \\<= CADe Device percentage (i.e. test of superiority)', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'sADR is defined as the percentage of patients with at least one adenoma 5mm or smaller detected.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat'}, {'type': 'SECONDARY', 'title': 'Polyps Per Colonoscopy (PPC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '694', 'groupId': 'OG000'}, {'value': '713', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colonoscopy (Standard of Care)', 'description': 'The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.'}, {'id': 'OG001', 'title': 'CADe Device', 'description': "The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.\n\nComputer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making."}], 'classes': [{'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.95', 'upperLimit': '1.11'}, {'value': '1.32', 'groupId': 'OG001', 'lowerLimit': '1.24', 'upperLimit': '1.41'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1', 'description': 'PPC is defined as the total number of histologically-confirmed polyps found divided by the total number of colonoscopies performed, per study arm.', 'unitOfMeasure': 'Polyps per colonoscopy', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat'}, {'type': 'SECONDARY', 'title': 'Advanced Adenoma Detection Rate (aADR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '694', 'groupId': 'OG000'}, {'value': '713', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colonoscopy (Standard of Care)', 'description': 'The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.'}, {'id': 'OG001', 'title': 'CADe Device', 'description': "The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.\n\nComputer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making."}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8194', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '2.6', 'pValueComment': 'Nominal p-value', 'groupDescription': 'Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \\<= CADe Device percentage (i.e. test of superiority)', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'aADR is defined as the percentage of patients with at least one adenoma ≥ 10 mm, or any adenoma \\< 10 mm, which was either of high-grade dysplasia (HGD) or villous or tubulovillous.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}, {'type': 'SECONDARY', 'title': 'False Positive Rate (FPR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '694', 'groupId': 'OG000'}, {'value': '713', 'groupId': 'OG001'}]}, {'units': 'Resected lesions', 'counts': [{'value': '715', 'groupId': 'OG000'}, {'value': '939', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colonoscopy (Standard of Care)', 'description': 'The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.'}, {'id': 'OG001', 'title': 'CADe Device', 'description': "The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.\n\nComputer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making."}], 'classes': [{'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000', 'lowerLimit': '0.19', 'upperLimit': '0.26'}, {'value': '0.31', 'groupId': 'OG001', 'lowerLimit': '0.28', 'upperLimit': '0.35'}]}]}], 'analyses': [{'pValue': '0.0008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.39', 'ciLowerLimit': '1.14', 'ciUpperLimit': '1.69', 'pValueComment': 'Nominal p-value', 'statisticalMethod': 'Exact poisson', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Test for difference'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1', 'description': 'FPR is defined as the proportion of colorectal lesions resected and biopsied and subsequently not histologically-confirmed to be clinically relevant colorectal polyps (e.g. a pathology finding of normal mucosa, inflammatory tissue, stool or debris, lymphoid aggregates).', 'unitOfMeasure': 'proportion of resected lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Resected lesions', 'denomUnitsSelected': 'Resected lesions', 'populationDescription': 'Intent-to-Treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Colonoscopy (Standard of Care)', 'description': 'The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.'}, {'id': 'FG001', 'title': 'CADe Device', 'description': "The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.\n\nComputer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '694'}, {'groupId': 'FG001', 'numSubjects': '716'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '694'}, {'groupId': 'FG001', 'numSubjects': '713'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '694', 'groupId': 'BG000'}, {'value': '713', 'groupId': 'BG001'}, {'value': '1407', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Colonoscopy (Standard of Care)', 'description': 'The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.'}, {'id': 'BG001', 'title': 'CADe Device', 'description': "The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.\n\nComputer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.42', 'spread': '8.94', 'groupId': 'BG000'}, {'value': '60.66', 'spread': '9.16', 'groupId': 'BG001'}, {'value': '60.54', 'spread': '9.05', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '369', 'groupId': 'BG000'}, {'value': '383', 'groupId': 'BG001'}, {'value': '752', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '325', 'groupId': 'BG000'}, {'value': '330', 'groupId': 'BG001'}, {'value': '655', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '652', 'groupId': 'BG000'}, {'value': '666', 'groupId': 'BG001'}, {'value': '1318', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '551', 'groupId': 'BG000'}, {'value': '561', 'groupId': 'BG001'}, {'value': '1112', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Colonoscopy Indication', 'classes': [{'categories': [{'title': 'Screening', 'measurements': [{'value': '373', 'groupId': 'BG000'}, {'value': '377', 'groupId': 'BG001'}, {'value': '750', 'groupId': 'BG002'}]}, {'title': 'Surveillance', 'measurements': [{'value': '277', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '558', 'groupId': 'BG002'}]}, {'title': 'Diagnostic (symptomatic)', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-29', 'size': 468774, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-10-25T18:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Subjects, investigators, study site personnel, and pathologists will not be blinded to treatment assignments. All Verily personnel involved in the statistical analysis of this study will be blinded to treatment assignment. For the interim analysis, unblinded analysis will be performed by an independent statistician, the results of which will be communicated to a select group of Verily personnel not involved in the study management.'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1410}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2022-02-25', 'resultsFirstSubmitDate': '2023-10-26', 'studyFirstSubmitQcDate': '2022-03-07', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-19', 'studyFirstPostDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in Adenomas Per Colonoscopy (APC)', 'timeFrame': 'Day 1', 'description': 'Difference in Adenomas Per Colonoscopy (APC) between the control and intervention arm, evaluated for superiority. APC is defined as the average number of histologically confirmed adenomas resected per colonoscopy.'}, {'measure': 'Difference in Positive Percent Agreement (PPA)', 'timeFrame': 'Day 1', 'description': 'Difference in Positive Percent Agreement (PPA) between the control and intervention arm, evaluated for non-inferiority. PPA is defined as the total number of histologically confirmed Clinically Significant Excised Lesions, divided by the total number of excisions.'}], 'secondaryOutcomes': [{'measure': 'Adenoma Detection Rate (ADR)', 'timeFrame': 'Day 1', 'description': 'The Adenoma Detection Rate is defined as the number of patients with at least one histologically confirmed adenoma divided by the total number of patients enrolled per study arm.'}, {'measure': 'Number of False Alerts Per Procedure', 'timeFrame': 'Day 1', 'description': 'A false alert is defined as a bounding box that persists on the screen (approximately 2-3 seconds per the judgment of the colonoscopist) that is then determined by the colonoscopist not to contain a polyp. The false alert rate is calculated as the number of false alerts per procedure conducted in the intervention arm of the study.'}, {'measure': 'Mean Withdrawal and Inspection Time (MWT)', 'timeFrame': 'Day 1', 'description': 'The withdrawal time is defined as the time measured from the moment the withdrawal phase of the procedure begins (with the scope in the cecum) to the moment the scope is withdrawn from the patient. The Inspection time measurement will exclude washing and resection, and other peri-resection activity not deemed to be colonic inspection. Inspection times for both the control arm and intervention arm will be calculated retrospectively upon review of the video recordings.'}, {'measure': 'Polyp Detection Rate (PDR)', 'timeFrame': 'Day 1', 'description': 'Polyp detection rate is defined as the proportion of patients with at least one histologically-confirmed polyp detected.'}, {'measure': 'Proximal Adenoma Detection Rate (pADR)', 'timeFrame': 'Day 1', 'description': 'pADR is defined as the percentage of patients with at least one histologically-confirmed adenoma detected in proximal colon.'}, {'measure': 'Flat Adenoma Detection Rate (fADR)', 'timeFrame': 'Day 1', 'description': 'fADR is defined as the percentage of patients with at least one histologically-confirmed non-polypoid adenoma detected.'}, {'measure': 'Serrated Lesions Per Colonoscopy (SLPC)', 'timeFrame': 'Day 1', 'description': 'SLPC is defined as the number of histologically confirmed serrated lesions detected, divided by the total number of colonoscopies.'}, {'measure': 'Serrated Lesions Detection Rate (SLDR)', 'timeFrame': 'Day 1', 'description': 'SLDR is defined as the percentage of patients with at least one histologically confirmed serrated lesion detected.'}, {'measure': 'Adenoma Detection Rate Including Carcinoma (ADR*)', 'timeFrame': 'Day 1', 'description': 'ADR\\* is defined as ADR, but also includes histologically-confirmed intramucosal carcinoma and adenocarcinoma.'}, {'measure': 'Small Adenoma Detection Rate (sADR)', 'timeFrame': 'Day 1', 'description': 'sADR is defined as the percentage of patients with at least one adenoma 5mm or smaller detected.'}, {'measure': 'Polyps Per Colonoscopy (PPC)', 'timeFrame': 'Day 1', 'description': 'PPC is defined as the total number of histologically-confirmed polyps found divided by the total number of colonoscopies performed, per study arm.'}, {'measure': 'Advanced Adenoma Detection Rate (aADR)', 'timeFrame': 'Day 1', 'description': 'aADR is defined as the percentage of patients with at least one adenoma ≥ 10 mm, or any adenoma \\< 10 mm, which was either of high-grade dysplasia (HGD) or villous or tubulovillous.'}, {'measure': 'False Positive Rate (FPR)', 'timeFrame': 'Day 1', 'description': 'FPR is defined as the proportion of colorectal lesions resected and biopsied and subsequently not histologically-confirmed to be clinically relevant colorectal polyps (e.g. a pathology finding of normal mucosa, inflammatory tissue, stool or debris, lymphoid aggregates).'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Colon Adenoma', 'Colon Polyp', 'Colon Lesion']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multicenter, randomized controlled study to evaluate the effect of the Computer-Assisted Detection (CADe) Device on Adenomas Per Colonoscopy and Positive Percent Agreement for routine colonoscopies. The control arm is colonoscopy performed with High Definition White Light Endoscopy (HD-WLE) per standard of care. The intervention arm is colonoscopy performed with HD-WLE per standard of care plus the Computer-Assisted Detection (CADe) Device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled to undergo routine screening (including, but not limited to, FIT/Cologuard positive), routine surveillance (≥3 years as scheduled since last colonoscopy), or diagnostic (symptomatic) colonoscopy with High Definition White Light Endoscopy.\n* Between the ages of 45 and 80 years, inclusive\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Self-reported pregnancy\n* Known diagnosis of Colorectal Cancer\n* History of, or referral for, Inflammatory Bowel Disease\n* Previous surgery involving the colon or rectum\n* Referral for known polyp or assessment of post-polypectomy site (i.e. less than 3 years since last colonoscopy).\n* High suspicion or diagnosis of genetic polyposis syndromes, including familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC), or any other high-risk family history meeting Bethesda guidelines.\n* Referral for overt, symptomatic gastrointestinal bleeding'}, 'identificationModule': {'nctId': 'NCT05275556', 'acronym': 'GAIN', 'briefTitle': 'Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Verily Life Sciences LLC'}, 'officialTitle': 'Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)', 'orgStudyIdInfo': {'id': '103820'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Colonoscopy (Standard of Care)', 'description': 'The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.'}, {'type': 'EXPERIMENTAL', 'label': 'CADe Device', 'description': 'The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.', 'interventionNames': ['Device: Computer-Assisted Detection (CADe) Device']}], 'interventions': [{'name': 'Computer-Assisted Detection (CADe) Device', 'type': 'DEVICE', 'description': "The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making.", 'armGroupLabels': ['CADe Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Health', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44060', 'city': 'Mentor', 'state': 'Ohio', 'country': 'United States', 'facility': 'Great Lakes Gastroenterology Research', 'geoPoint': {'lat': 41.66616, 'lon': -81.33955}}, {'zip': '17011', 'city': 'Camp Hill', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Susquehanna Research Group', 'geoPoint': {'lat': 40.23981, 'lon': -76.91997}}, {'zip': '79912', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'ANRC Research', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'city': 'Haifa', 'country': 'Israel', 'facility': 'Elisha Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Sourasky Medical Center (Ichilov)', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Scooter Plowman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Verily Life Sciences LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Verily Life Sciences LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}