Viewing Study NCT05823792


Ignite Creation Date: 2025-12-24 @ 3:36 PM
Ignite Modification Date: 2025-12-28 @ 1:24 AM
Study NCT ID: NCT05823792
Status: UNKNOWN
Last Update Posted: 2023-04-21
First Post: 2023-04-09
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Performance of Artificial Intelligence Tools and Ultrasonographers With Different Skills
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Samples Without DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-05-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-09', 'studyFirstSubmitDate': '2023-04-09', 'studyFirstSubmitQcDate': '2023-04-09', 'lastUpdatePostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ultrasound diagnosis of ileocolic intussusception', 'timeFrame': 'April 9, 2023 to May 10, 2023', 'description': 'Ultrasound diagnosis of ileocolic intussusception'}], 'secondaryOutcomes': [{'measure': 'Surgical indication of ileocolic intussusception identified by ultrasound', 'timeFrame': 'April 9, 2023 to May 10, 2023', 'description': 'Surgical indication of ileocolic intussusception identified by ultrasound'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ileocolic Intussusception']}, 'descriptionModule': {'briefSummary': 'Artificial intelligence versus different skilled sonographers.', 'detailedDescription': 'Comparison of artificial intelligence and ultrasonographers with different skills in diagnosing intussusception in children and identifying indications for surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '3 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children aged 3-36 months with suspected ileocolic intussusception', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 3-36 months with suspected ileocolic intussusception\n\nExclusion Criteria:\n\n* Children younger than 3 months or older than 36 months with suspected ileocolic intussusception'}, 'identificationModule': {'nctId': 'NCT05823792', 'acronym': 'PAITUWDS', 'briefTitle': 'Performance of Artificial Intelligence Tools and Ultrasonographers With Different Skills', 'organization': {'class': 'OTHER', 'fullName': "Guangzhou Women and Children's Medical Center"}, 'officialTitle': 'Comparison of Artificial Intelligence and Ultrasonographers With Different Skills in Diagnosing Intussusception in Children and Identifying Indications for Surgery', 'orgStudyIdInfo': {'id': 'GuangzhouWCMC20230409'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients aged 3-36 months with suspected ileocolic intussusception', 'description': 'Patients aged 3-36 months with suspected ileocolic intussusception', 'interventionNames': ['Diagnostic Test: Non-invasive diagnosis of ileocolic intussusception by ultrasound with indication for surgery']}], 'interventions': [{'name': 'Non-invasive diagnosis of ileocolic intussusception by ultrasound with indication for surgery', 'type': 'DIAGNOSTIC_TEST', 'description': 'Non-invasive diagnosis of ileocolic intussusception by ultrasound with indication for surgery', 'armGroupLabels': ['Patients aged 3-36 months with suspected ileocolic intussusception']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510623', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongkui Yu,', 'role': 'CONTACT', 'email': 'hongkuiyu@126.com', 'phone': '+86 18938691272'}], 'facility': 'Hongkui Yu, MD', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Hongkui Yu', 'role': 'CONTACT', 'email': 'hongkuiyu@126.com', 'phone': '+86 18938691272'}], 'overallOfficials': [{'name': 'Hongkui Yu,', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guangzhou Women and Children's Medical Center"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'After May 20, 2023', 'ipdSharing': 'YES', 'description': 'For non-commercial use in research, you can contact Prof. Hongkui Yu to get the data at hongkuiyu@126.com.', 'accessCriteria': 'For non-commercial use in research, you can contact Prof. Hongkui Yu to get the data at hongkuiyu@126.com.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hongkui Yu, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Hongkui Yu, MD', 'investigatorAffiliation': "Guangzhou Women and Children's Medical Center"}}}}