Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-04 @ 7:05 AM
Study NCT ID:
NCT06546904
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-09
First Post:
2024-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Artificial Intelligence Empowered Anesthesia Ultrasound Guided Regional Anesthesia Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-06', 'studyFirstSubmitDate': '2024-08-03', 'studyFirstSubmitQcDate': '2024-08-06', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of ultrasound-guided puncture', 'timeFrame': '1day', 'description': 'Success rate of ultrasound-guided puncture at the first attempt'}], 'secondaryOutcomes': [{'measure': 'Location time', 'timeFrame': '1day', 'description': 'the time from the placement of the US transducer on the skin to the time of piercing of the skin.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['artificial intelligence', 'ultrasound-guided regional anesthesia'], 'conditions': ['Ultrasound-guided Regional Anesthesia']}, 'descriptionModule': {'briefSummary': 'Evaluate the effectiveness of AI powered anesthesia ultrasound in ultrasound-guided regional anesthesia (UGRA) training.', 'detailedDescription': "The AI powered anesthesia ultrasound system integrates ScanNav and NeedleTrainer modules, providing real-time training for medical staff to simulate punctures. Combined with ScanNav's real-time anatomical structure recognition function, it is expected to significantly enhance the training effectiveness of ultrasound-guided regional anesthesia technology."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntary participants;\n* Sign the informed consent form.\n\nExclusion Criteria:\n\n* allergic to ultrasound coupling agents'}, 'identificationModule': {'nctId': 'NCT06546904', 'briefTitle': 'Artificial Intelligence Empowered Anesthesia Ultrasound Guided Regional Anesthesia Training', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Evaluation of the Effectiveness of Artificial Intelligence Empowered Ultrasound in Regional Anesthesia Training', 'orgStudyIdInfo': {'id': 'AISR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AI group', 'description': 'Group AI used artificial intelligence to empower anesthesia ultrasound assisted simulated PNB operations in 5 areas', 'interventionNames': ['Device: Artificial intelligence empowers anesthesia with ultrasound assistance']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Control group did not use AI assisted simulated PNB operations in 5 areas'}], 'interventions': [{'name': 'Artificial intelligence empowers anesthesia with ultrasound assistance', 'type': 'DEVICE', 'description': 'Artificial intelligence empowers anesthesia with ultrasound assistance', 'armGroupLabels': ['AI group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'aijun Xu, Dr.', 'role': 'CONTACT', 'email': '70663307@qq.com', 'phone': '02783663625'}, {'name': 'aihua Du, Dr.', 'role': 'CONTACT', 'email': '70663307@qq.com', 'phone': '02783663625'}], 'overallOfficials': [{'name': 'mujun Chang, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Tongji Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'aijun xu', 'investigatorAffiliation': 'Tongji Hospital'}}}}