Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT04277169
Status:
COMPLETED
Last Update Posted:
2021-02-17
First Post:
2020-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Volunteer Study to Collect Imaging Data for the Development of the IntelligentUltrasound Anatomy Guide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2020-01-23', 'studyFirstSubmitQcDate': '2020-02-18', 'lastUpdatePostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Model development and verification', 'timeFrame': '4 months', 'description': 'Collection of ultrasound scans. The collected scans will be assessed and used in the development and verification of deep-learning models that identify the target structures using a training dataset.'}], 'secondaryOutcomes': [{'measure': 'Model validation', 'timeFrame': '4 months', 'description': 'Estimation of performance and accuracy (e.g. success/failure of highlighting of target structures, average distance of highlighting from target, time spent highlighting correct structure as a proportion of time target visible)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ultrasound Imaging of Anatomical Structures']}, 'descriptionModule': {'briefSummary': 'This is a single-centre, prospective, non-randomised volunteer study to be undertaken in the MediCentre, Heath Park, Cardiff, UK', 'detailedDescription': 'This is a single-centre, non-randomised, prospective study involving at least 120 participants. The data collected in this study will augment the data collected in IU2019\\_AG\\_03 Volunteers will be enrolled sequentially until at least 120 scans have been recorded. Ideally, between 120 and 150 scans will be recorded.\n\nPhase I Data collected from up to the first 80 participants in each of the six peripheral nerve block areas will be used as a training/verification set. This set will be used to develop and verify models for the identification and highlighting of target anatomical structures on ultrasound images.\n\nPhase II The remaining 40 videos in each area (total minimum 120 participants) will be used for validation of these models.\n\nThe validation videos will be fed into the models created during Phase I of the study and the output anatomy highlighting will be recorded as a separate video, overlaid on the original ultrasound image. The overlay video will then be further split into 30-second segments.\n\nA panel of three independent expert anaesthetists will be convened to review and score the segments for accuracy and performance to the endpoints agreed in Phase I of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers who respond to adverts placed at the University Hospital of Wales (UHW) and related sites in Cardiff.', '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': 'NCT04277169', 'briefTitle': 'A Volunteer Study to Collect Imaging Data for the Development of the IntelligentUltrasound Anatomy Guide', 'organization': {'class': 'INDUSTRY', 'fullName': 'IntelligentUltrasound Limited'}, 'officialTitle': 'A Volunteer Study to Collect Imaging Data for the Development of the IntelligentUltrasound Anatomy Guide', 'orgStudyIdInfo': {'id': 'IU2020_AG_04'}}, 'contactsLocationsModule': {'locations': [{'zip': 'CF14 4UJ', 'city': 'Cardiff', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'MediCentre, Heath Park', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}], 'overallOfficials': [{'name': 'Steve Margetts', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IntelligentUltrasound Limited'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IntelligentUltrasound Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}