Ignite Creation Date:
2025-12-25 @ 12:30 AM
Ignite Modification Date:
2026-01-01 @ 8:10 PM
Study NCT ID:
NCT04883567
Status:
UNKNOWN
Last Update Posted:
2021-05-12
First Post:
2021-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of AI to Improve Quality of OGD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004415', 'term': 'Dyspepsia'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-11', 'studyFirstSubmitDate': '2021-04-27', 'studyFirstSubmitQcDate': '2021-05-11', 'lastUpdatePostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of sites inspected during OGD', 'timeFrame': 'During the procedure', 'description': 'There is a standardised 28 sites the trainee endoscopist need to inspect'}], 'secondaryOutcomes': [{'measure': 'Overall inspection time', 'timeFrame': 'During the procedure', 'description': 'The overall inspection time during the OGD would be recorded in terms of seconds'}, {'measure': 'The individual sites inspection time', 'timeFrame': 'During the procedure', 'description': 'The individual inspection time of the 28 sites during OGD would be recorded in terms of seconds'}, {'measure': 'The number of positive pathologies found on OGD', 'timeFrame': 'during the procedure', 'description': 'The number of positive pathologies found on OGD would be recorded'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oesophagogastroduodenoscopy (OGD)', 'artificial intelligence', 'quality of OGD'], 'conditions': ['Dyspepsia', 'Anemia', 'Acid Reflux', 'Dysphagia']}, 'descriptionModule': {'briefSummary': 'Early and accurate recognition of gastrointestinal lesions has implications for public health. The quality of oesophagogastroduodenoscopy (OGD) has great impact on the detection of oesophageal and gastric malignancies. An AI system, Cerebro, has been developed as a real-time recognition of a pre-defined 28 locations. This system would alert the endoscopist if the sites were not inspected with adequate time. The aim of the study is to investigate the use of AI in endoscopists-in-training during OGD to provide a real-time feedback for ensuring compliance to a standardized protocol for examination. The hypothesis is that the use of AI system Cerebro will significantly improve the compliance to the protocol and thereby reduce the blind spot rates of OGD, ensure adequate inspection time and ensure adequate photodocumentation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study includes all patients who require an OGD in the Prince of Wales Hospital. The inclusion and exclusion criteria were stated in the previous section.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. All patients aged \\>= 18 years old\n2. Undergoing diagnostic OGD for evaluation of their symptoms in the Prince of Wales Hospital will be included in the study.\n\nExclusion Criteria:\n\n1. Patients in which a full endoscopic examination is not required including patients with a specific diagnostic purpose without the need for a full evaluation, follow-up endoscopy within 8 weeks for a previously diagnosed disease or condition,\n2. Patients' condition requiring therapeutic endoscopy,\n3. Early termination of endoscopy due to patient intolerance, presence of large amount of food residue, presence of mechanical obstruction or for reasons of safety,\n4. Patients with altered anatomy such as history of esophagectomy, gastrectomy, gastric bypass surgery, or Whipple's operation,\n5. Patient who are not suitable for EGD examination (such as acute peritonitis with suspected perforated bowel)\n6. Pregnant females\n7. Patients who refuse to participate in the study\n8. Patients who are unfit for consent."}, 'identificationModule': {'nctId': 'NCT04883567', 'briefTitle': 'The Use of AI to Improve Quality of OGD', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'The Use of Artificial Intelligence Real-time Feedback to Improve Compliance to a Standardised Protocol and Procedural Quality During Oesophagogastroduodenoscopy (OGD)', 'orgStudyIdInfo': {'id': '2021.061'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AI arm', 'description': 'AI would be used to assist the trainee endoscopist', 'interventionNames': ['Diagnostic Test: The use of artificial intelligence system Cerebro']}, {'label': 'Non-AI arm', 'description': 'Trainee endoscopist would perform OGD as usual.'}], 'interventions': [{'name': 'The use of artificial intelligence system Cerebro', 'type': 'DIAGNOSTIC_TEST', 'description': 'The artificial intelligence system Cerebro would be used during OGD', 'armGroupLabels': ['AI arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Shannon Chan', 'role': 'CONTACT', 'email': 'shannonchan@surgery.cuhk.edu.hk', 'phone': '35052627'}], 'facility': 'The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Shannon Chan', 'role': 'CONTACT', 'email': 'shannonchan@surgery.cuhk.edu.hk', 'phone': '35052627'}, {'name': 'Philip Chiu', 'role': 'CONTACT', 'email': 'philipchiu@surgery.cuhk.edu.hk', 'phone': '35052627'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'CHAN SHANNON MELISSA', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}