Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:02 AM
Study NCT ID:
NCT06742905
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-19
First Post:
2024-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Echo Acquisition Despite Geographic Separation by Replication of Human Movements (EAGER)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-16', 'studyFirstSubmitDate': '2024-12-16', 'studyFirstSubmitQcDate': '2024-12-16', 'lastUpdatePostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion complete', 'timeFrame': '1 hour', 'description': 'Proportion of a standard acquisition protocol obtainable using robotic acquisition over 1 hour'}], 'secondaryOutcomes': [{'measure': 'Proportion complete', 'timeFrame': '1 hour', 'description': 'Proportion of echo views with the same information provided by conventional echo'}, {'measure': 'Proportion diagnostic features correctly identified by robotic echo', 'timeFrame': '1 hour', 'description': 'Proportion diagnostic features correctly identified by robotic echo'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Echocardiography'], 'conditions': ['Echocardiography']}, 'descriptionModule': {'briefSummary': 'Echocardiography is a cornerstone of modern cardiology management, but access in rural and remote areas is limited. We have developed a robot ("Edler" named after the originator of echocardiography) which enables a sonographer to complete an examination at a distance. This study seeks to compare the images obtained by both methods, the completeness of the exam over a feasible time, and to identify particular components of the exam that are difficult to obtain using the robot.', 'detailedDescription': 'The EAGER study is an effectiveness and feasibility trial of robot -assisted echo.\n\nPatients who have undergone a standard echo will be asked to have a repeat study with a different sonographer, working remotely, obtaining images using the robot. This study is limited to 1 hour and as many views as possible will be obtained. During the study, the remote sonographer and patient are in direct contact over a video link. Another person will be in the room with the patient and the patient will be instructed on the use of a stop switch which will disengage the robot if they feel uncomfortable.\n\nThe acquired images will be saved to the imaging cloud and interpreted by an imaging specialist blinded to the original echocardiogram. A side-by-side comparison will be undertaken for each view, and image quality and study completeness will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having a conventional echocardiogram\n\nExclusion Criteria:\n\n* Declined consent to undergo both examinations'}, 'identificationModule': {'nctId': 'NCT06742905', 'acronym': 'EAGER', 'briefTitle': 'Echo Acquisition Despite Geographic Separation by Replication of Human Movements (EAGER)', 'organization': {'class': 'OTHER', 'fullName': 'Baker Heart and Diabetes Institute'}, 'officialTitle': 'Echocardiographic Acquisition With Geographic Separation of Patients and Sonographers With Roboot Assistance (EAGER)', 'orgStudyIdInfo': {'id': 'BakerHeartDiabetesI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard echo', 'description': 'Standard echo exam provided by a sonographer using a standard view template', 'interventionNames': ['Diagnostic Test: Standard echocardiogram']}, {'type': 'EXPERIMENTAL', 'label': 'Robotic echo', 'description': 'Robotic echo exam provided by a sonographer using a standard view template', 'interventionNames': ['Diagnostic Test: Robot-guided echo']}], 'interventions': [{'name': 'Robot-guided echo', 'type': 'DIAGNOSTIC_TEST', 'description': 'This echo will be performed by a remote sonographer, though a robot', 'armGroupLabels': ['Robotic echo']}, {'name': 'Standard echocardiogram', 'type': 'DIAGNOSTIC_TEST', 'description': "Echocardiogram acquired by a sonographer at the patient's bedside", 'armGroupLabels': ['Standard echo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'contacts': [{'name': 'Leah Wright, BSc, PhD', 'role': 'CONTACT', 'email': 'leah.wright@baker.edu.au', 'phone': '+61 3 8532 1550'}, {'name': 'Elizabeth Dewar, BSc', 'role': 'CONTACT', 'email': 'liz.dewar@baker.edu.au', 'phone': '+61 3 8532 1550'}, {'name': 'Thomas Marwick, MBBS, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mats Isaksson, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Baker Heart and Diabetes Institute', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'centralContacts': [{'name': 'Thomas H Marwick, MBBS, PhD, MPH', 'role': 'CONTACT', 'email': 'tom.marwick@baker.edu.au', 'phone': '0385321550'}]}, 'ipdSharingStatementModule': {'url': 'https://www.baker.edu.au/research/laboratories/imaging-research', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Dates - material will be made available immediately following publication, with no end date.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data that underlie the results reported in this project (text, tables, figures and appendices) will be made available.', 'accessCriteria': 'The authors are pleased to collaborate with other researchers who provide a methodologically sound proposal, to achieve the aims of the approved proposal, including individual participant data meta-analysis.\n\nProposals should be directed to tom.marwick@baker.edu.au. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baker Heart and Diabetes Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}