Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT07171502
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-12
First Post:
2025-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AI-Assisted Ultrasound-Guided Nerve Block: Model Development and Performance Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2025-09-08', 'studyFirstSubmitQcDate': '2025-09-08', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The accuracy of identifying the target anatomical structures in the annotated images.', 'timeFrame': 'From enrollment to the end of treatment at 4 months'}], 'secondaryOutcomes': [{'measure': 'The number of true positive (TP) structures', 'timeFrame': 'From enrollment to the end of treatment at 4 months'}, {'measure': 'The number of false positive (FP) structures', 'timeFrame': 'From enrollment to the end of treatment at 4 months'}, {'measure': 'The number of true negative (TN) structures', 'timeFrame': 'From enrollment to the end of treatment at 4 months'}, {'measure': 'The number of false negative (FN) structures', 'timeFrame': 'From enrollment to the end of treatment at 4 months'}, {'measure': 'The annotation time (time from the start to the end of annotation)', 'timeFrame': 'From enrollment to the end of treatment at 4 months'}, {'measure': 'An evaluation of the AI model if applied to assist in performing ultrasound-guided regional blocks: a) its impact on block failure rate (increase, no effect, decrease); b) its impact on the incidence of adverse events (increase, no effect, decrease)', 'timeFrame': 'From enrollment to the end of treatment at 4 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['AI (Artificial Intelligence)', 'Ultrasound-Guided Nerve Blocks']}, 'descriptionModule': {'briefSummary': "This study intends to have experts with over 10 years of experience in ultrasound-guided regional anesthesia acquire 1,000 target images. These images will be annotated by both an AI model and human experts, and the model's annotations will be evaluated by a panel of 10 specialists. The primary outcome is the accuracy of identifying the target anatomical structures in the annotated images. Secondary outcomes include the number of true positive, false positive, true negative, and false negative structures, the time required for annotation, and the potential application of the AI model in assisting the performance of ultrasound-guided regional blocks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ① Aged 18-70 years;\n\n * BMI between 19-23 kg·m-²; ③ ASA physical status classification I-II; ④ Normal orientation and able to cooperate with physical examination.\n\nExclusion Criteria:\n\n* ①Patient refusal;\n\n * Infection, trauma, skin defect, deformity, or other abnormalities at the intended nerve block site; ③Pregnancy;'}, 'identificationModule': {'nctId': 'NCT07171502', 'acronym': 'AI', 'briefTitle': 'AI-Assisted Ultrasound-Guided Nerve Block: Model Development and Performance Assessment', 'organization': {'class': 'OTHER', 'fullName': "Shanghai Jiao Tong University Affiliated Sixth People's Hospital"}, 'officialTitle': 'AI-Assisted Ultrasound-Guided Nerve Block: Model Development and Performance Assessment', 'orgStudyIdInfo': {'id': 'AI-Sacral Plexus'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AI Annotation', 'interventionNames': ['Device: AI Annotation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Manual Annotation', 'interventionNames': ['Other: manual annotation']}], 'interventions': [{'name': 'AI Annotation', 'type': 'DEVICE', 'description': 'Use the AI model to assist in annotating the target images.', 'armGroupLabels': ['AI Annotation']}, {'name': 'manual annotation', 'type': 'OTHER', 'description': 'Use the manual to annotate the target images.', 'armGroupLabels': ['Manual Annotation']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai Jiao Tong University Affiliated Sixth People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal', 'investigatorFullName': 'Tao Xu', 'investigatorAffiliation': "Shanghai Jiao Tong University Affiliated Sixth People's Hospital"}}}}