Ignite Creation Date:
2025-12-25 @ 12:30 AM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
Study NCT ID:
NCT06741267
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-12-18
First Post:
2024-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Assessment of the Feasibility and Operational Performance of Automated System Bronchoscopy in a Simulated Environment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-16', 'studyFirstSubmitDate': '2024-12-05', 'studyFirstSubmitQcDate': '2024-12-16', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sampling time', 'timeFrame': 'During the bronchoscopy', 'description': 'Sampling time , the time used to sample'}], 'secondaryOutcomes': [{'measure': 'Total time', 'timeFrame': 'During the bronchoscopy', 'description': 'total procedure time'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Compare Operational Performance of Three Technology in Lung Models']}, 'referencesModule': {'references': [{'pmid': '37619664', 'type': 'BACKGROUND', 'citation': "Cold KM, Xie S, Nielsen AO, Clementsen PF, Konge L. Artificial Intelligence Improves Novices' Bronchoscopy Performance: A Randomized Controlled Trial in a Simulated Setting. Chest. 2024 Feb;165(2):405-413. doi: 10.1016/j.chest.2023.08.015. Epub 2023 Aug 23."}]}, 'descriptionModule': {'briefSummary': 'Recruit 30 trainee physicians from 6 centers and compare their performance in operating lung models using automatic bronchoscopy, robotic bronchoscopy, and electromagnetic navigation bronchoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The recruited participants were respiratory internal medicine trainees undergoing further training.\n2. They were willing to undertake relevant training and complete the experiment persistently -\n\nExclusion Criteria:\n\nIf the participant has any previous clinical or simulated experiences involving electromagnetic navigation bronchoscopy, robotic bronchoscopy system, or fluoroscopy bronchoscopy, they will be excluded.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06741267', 'briefTitle': 'The Assessment of the Feasibility and Operational Performance of Automated System Bronchoscopy in a Simulated Environment', 'organization': {'class': 'OTHER', 'fullName': 'Guangzhou Medical University'}, 'officialTitle': 'The Assessment of the Feasibility and Operational Performance of Automated System Bronchoscopy in a Simulated Environment: a Multicenter, Randomized-Controlled Trial.', 'orgStudyIdInfo': {'id': 'automatic bronchoscopy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'RBS group', 'description': 'physicians control robotic bronchoscopy system(RBS)', 'interventionNames': ['Device: RBS']}, {'type': 'OTHER', 'label': 'AB group', 'description': 'physicians control automatic bronchoscopy(AB)', 'interventionNames': ['Device: AB']}, {'type': 'OTHER', 'label': 'ENB groups', 'description': 'physicians control electromagnetic navigation bronchoscopy(ENB)', 'interventionNames': ['Device: ENB']}], 'interventions': [{'name': 'RBS', 'type': 'DEVICE', 'description': 'physicians control RBS', 'armGroupLabels': ['RBS group']}, {'name': 'AB', 'type': 'DEVICE', 'description': 'physician control automatic bronchoscopy', 'armGroupLabels': ['AB group']}, {'name': 'ENB', 'type': 'DEVICE', 'description': 'physicians control electromagnetic bronchoscopy', 'armGroupLabels': ['ENB groups']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510100', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'Chad', 'facility': 'The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Li Shiyue', 'investigatorAffiliation': 'Guangzhou Medical University'}}}}