Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-03-18 @ 11:36 PM
Study NCT ID:
NCT07046234
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-10-03
First Post:
2025-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Point of Care Lung Ultrasound Examination in Patients With Shortness of Breath
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-06-06', 'studyFirstSubmitQcDate': '2025-06-23', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cohort 1: % of patient studies composed of images acquired by the THCPs with sufficient quality to make a clinical assessment', 'timeFrame': '7 months', 'description': 'The primary endpoint will be based on the majority assessment of the independent expert readers qualitatively assessment of the LUS exam (study level) as being of diagnostic quality.'}, {'measure': 'Cohort 2: % of patient studies composed of images acquired by the Qualified user to make a clinical assessment', 'timeFrame': '7 months', 'description': 'The primary endpoint will be based on the majority assessment of the independent expert readers qualitatively assessment of the LUS exam (study level) as being of diagnostic quality.'}], 'secondaryOutcomes': [{'measure': 'Cohort 1:', 'timeFrame': '7 months', 'description': 'Sub-group analyses will be performed on the diagnostic image quality performance, with descriptive statistics reported based on age (\\< 65, ≥ 65), BMI group (\\< 25, 25 ≤ BMI \\< 30, ≥ 30), gender (Male / Female), site location, THCP, and zone of the image (1 - 8). The statistical analysis procedure and all applicable performance metrics that were used on the whole sample (i.e., the Primary Outcome Measures) will be repeated for each sub-group level. This will be conducted to ensure that there is no inherent bias where a specific sub-group level has a greater impact on the overall whole-sample performance compared to other levels.'}, {'measure': 'Cohort 2:', 'timeFrame': '7 months', 'description': 'Sub-group analyses will be performed on the diagnostic image quality performance, with descriptive statistics reported based on age (\\< 65, ≥ 65), BMI group (\\< 25, 25 ≤ BMI \\< 30, ≥ 30), gender (Male / Female), site location, THCP, and zone of the image (1 -12). The statistical analysis procedure and all applicable performance metrics that were used on the whole sample (i.e., the Primary Outcome Measures) will be repeated for each sub-group level. This will be conducted to ensure that there is no inherent bias where a specific sub-group level has a greater impact on the overall whole-sample performance compared to other levels.'}, {'measure': 'Cohort 1:', 'timeFrame': '7 months', 'description': 'Task-based comparison of the study and control exams:\n\no Aided non-experts (i.e., THCP) and unaided experts (i.e., Expert LUS user) clips will be reviewed by expert readers for "normal" and "abnormal" ultrasound assessment at the zone level (B-lines, Pleural effusion, Non-aerated Lung / Consolidation, Lung Sliding).'}, {'measure': 'Cohort 2:', 'timeFrame': '7 months', 'description': 'Task-based comparison of the study and control exams:\n\no Aided user and unaided user (i.e., Qualified user) clips will be reviewed by expert readers for "normal" and "abnormal" ultrasound assessment at the zone level (B-lines, Pleural effusion, Non-aerated Lung / Consolidation, Lung Sliding).'}, {'measure': 'Cohort 1 and 2:', 'timeFrame': '7 months', 'description': 'Recording mode (% of clips acquired with auto-capture rate versus save best clip).'}, {'measure': 'Cohort 1:', 'timeFrame': '7 months', 'description': 'Acquisition time to complete the LUS exam and for each view (1 - 8).'}, {'measure': 'Cohort 2:', 'timeFrame': '7 months', 'description': 'Acquisition time to complete the LUS exam and for each view (1 - 12).'}, {'measure': 'Cohort 1 and 2:', 'timeFrame': '7 months', 'description': 'Inter-rater (physician image-interpretation) variability.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Lung Ultrasound', 'Artificial Intelligence'], 'conditions': ['Lung Disease', 'Lung Ultrasound']}, 'descriptionModule': {'briefSummary': 'This is a prospective, non-randomized clinical validation research study. Subjects will consent and have two ultrasounds as part of the study.', 'detailedDescription': 'This study is to collect data to validate the performance of Caption Lung AI in enabling trained healthcare professionals to perform LUS to obtain diagnostic-quality Lung Ultrasound Studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Patients over the age of 22; AND\n* 2\\. Patients with known lung pathology or patients with no known lung pathology in the hospital or presenting to the hospital or outpatient setting with shortness of breath.\n\nExclusion Criteria:\n\n* 1\\. Patients in extremis and/or patients in whom a lung ultrasound would not normally be performed;\n* 2\\. Patients who are unable to consent;\n* 3\\. Patients who are prisoners; AND\n* 4\\. Patients who do not speak English fluently.'}, 'identificationModule': {'nctId': 'NCT07046234', 'briefTitle': 'Point of Care Lung Ultrasound Examination in Patients With Shortness of Breath', 'organization': {'class': 'INDUSTRY', 'fullName': 'GE Healthcare'}, 'officialTitle': 'Point of Care Lung Ultrasound Examination in Patients With Shortness of Breath', 'orgStudyIdInfo': {'id': 'SA-000147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1 -Device 1', 'description': 'Cohort 1 will utilize the Vscan Air CL (curvilinear and linear probes) and SL (sector probe) handheld ultrasound to perform an 8-zone lung ultrasound (LUS) exam.\n\nThe Trained HCP will be required to capture at least 2 clips per zone using an ultrasound with Caption AI before moving onto the next zone. The scanner can capture multiple clips per zone, via-auto-capture or Save Best Clip (Study Exam).\n\nThe Expert LUS user will use the same ultrasound system but without Caption Lung AI (Control Exam).', 'interventionNames': ['Device: Lung ultrasound']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 -Device 2', 'description': 'Cohort 2 will utilize the Venue GO ultrasound system to perform a 12-zone lung ultrasound (LUS) exam.\n\nAll Qualified users using Caption Lung AI will be required to capture at least 2 clips per zone before moving onto the next zone. The scanner can capture multiple clips per zone, via-auto-capture or Save Best Clip (Study Exam).\n\nThe Qualified user will use the same ultrasound system but without Caption Lung AI (Control Exam).', 'interventionNames': ['Device: Lung ultrasound']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort 0 - Vscan (no AI)', 'description': 'Cohort 0 will utilize the Vscan Air CL (curvilinear and linear probes) and SL (sector probe) handheld ultrasound to perform the following lung ultrasound (LUS) exams.: Each patient will undergo 2 8-zone lung examinations which will be a combination of the enrollment distribution listed below equating to up to 30 subjects with 2 scans per subject (60 scans).', 'interventionNames': ['Device: Lung ultrasound']}], 'interventions': [{'name': 'Lung ultrasound', 'type': 'DEVICE', 'otherNames': ['SaMD'], 'description': 'Lung ultrasound software.', 'armGroupLabels': ['Cohort 0 - Vscan (no AI)', 'Cohort 1 -Device 1', 'Cohort 2 -Device 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '60612-3833', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60208', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GE Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Northwestern University', 'class': 'OTHER'}, {'name': 'Rush University Medical Center', 'class': 'OTHER'}, {'name': 'Yale University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}