Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-03 @ 6:24 PM
Study NCT ID:
NCT03883035
Status:
COMPLETED
Last Update Posted:
2020-01-30
First Post:
2019-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality Control of Esophagogastroduodenoscopy Using Real-time EGD Auxiliary System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1060}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-28', 'studyFirstSubmitDate': '2019-03-19', 'studyFirstSubmitQcDate': '2019-03-19', 'lastUpdatePostDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'detection rate of gastric neoplasms', 'timeFrame': '8 months', 'description': 'detection rate of gastric neoplasms in different groups'}], 'secondaryOutcomes': [{'measure': 'mean number of gastric neoplasms detected', 'timeFrame': '8 months', 'description': 'mean number of gastric neoplasms detected per procedure in different groups'}, {'measure': 'mean inspection completeness', 'timeFrame': '8 months', 'description': 'inspection completeness per procedure in different groups'}, {'measure': 'mean inspection time', 'timeFrame': '8 months', 'description': 'inspection time per procedure in different groups'}, {'measure': 'errors of EAS', 'timeFrame': '8 months', 'description': 'errors of EAS in EAS-aided group'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Esophagogastroduodenoscopy', 'gastric neoplasm', 'artificial intelligence', 'quality control'], 'conditions': ['Esophagogastroduodenoscopy']}, 'descriptionModule': {'briefSummary': 'The aim of our study was to develop an automatic quality-control system and assess the performance of this system in quality control of esophagogastroduodenoscopy.', 'detailedDescription': 'In this study, the researchers firstly developed an automatic quality-control system, name as EAS. Next, the researchers applied the system in a endoscopic center and designed a prospective randomised controlled trial to investigate the performance of the system in quality control of esophagogastroduodenoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing EGD examination with anaesthesia;\n* patients able to give informed consent.\n\nExclusion Criteria:\n\n* patients with the contraindications to EGD examination;\n* patients with a prior EGD examination within 1 year before the trial;\n* patients with frankly upper gastrointestinal malignant lesions that were apparent on endoscopy;\n* a history of upper gastrointestinal cancers;\n* allergic to anaesthetic in previous medical history;\n* patients refused to participate in the trial;\n* the EGD procedure cannot be completed due to stenosis, obstruction, solid food, or complications of anaesthesia.'}, 'identificationModule': {'nctId': 'NCT03883035', 'briefTitle': 'Quality Control of Esophagogastroduodenoscopy Using Real-time EGD Auxiliary System', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'Utilization of Real-time Automatic Quality-control System in the Detection of Gastric Neoplasms', 'orgStudyIdInfo': {'id': '2019SDU-QILU-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EAS-aided group', 'description': 'esophagogastroduodenoscopy examination with the assistance of automatic quality-control system', 'interventionNames': ['Other: automatic quality-control system']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'conventional standard esophagogastroduodenoscopy examination without the assistance of automatic quality-control system'}], 'interventions': [{'name': 'automatic quality-control system', 'type': 'OTHER', 'description': 'Automatic quality-control system could real-time measuring endoscopic inspection completeness, detecting gastric neoplasms and evaluating gastric mucosal visibility.', 'armGroupLabels': ['EAS-aided group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Department of Gastroenterology, Qilu Hospital, Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yanqing Li', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'vice president of Qilu Hospital', 'investigatorFullName': 'Yanqing Li', 'investigatorAffiliation': 'Shandong University'}}}}