Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT05992805
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2023-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ScanNav Anatomy PNB Data Collection Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-27', 'studyFirstSubmitDate': '2023-03-27', 'studyFirstSubmitQcDate': '2023-08-11', 'lastUpdatePostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Training and/or validation data (in the form of recorded ultrasound scans)', 'timeFrame': '6 months', 'description': 'Ultrasound scans to be used for training and/or validation of AI models developed in-house to assist ultrasound-guided regional anaesthesia.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Data Collection']}, 'descriptionModule': {'briefSummary': 'Study to gather additional data for AI-driven medical device, ScanNav Anatomy PNB.', 'detailedDescription': 'Volunteer study to gather additional ultrasound training and/or validation data for Artificial Intelligence (AI)-algorithms used in the medical device ScanNav Anatomy PNB.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy adult volunteers.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, at least 18 years of age;\n2. Able to comprehend and sign the Informed Consent prior to enrolment in the study.\n\nExclusion Criteria:\n\n1. Aged \\<18 years of age;\n2. Unwilling or unable to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT05992805', 'briefTitle': 'ScanNav Anatomy PNB Data Collection Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'IntelligentUltrasound Limited'}, 'officialTitle': 'ScanNav Anatomy PNB Data Collection Study', 'orgStudyIdInfo': {'id': 'IU2023_AG_11'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Volunteer Participants', 'description': 'Volunteer participants being scanned by a qualified clinician using various ultrasound machines.', 'interventionNames': ['Other: N/A - non-interventional study']}], 'interventions': [{'name': 'N/A - non-interventional study', 'type': 'OTHER', 'description': 'N/A - non-interventional study. Data collection only.', 'armGroupLabels': ['Volunteer Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CF10 1DY', 'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'Hodge House', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IntelligentUltrasound Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}