[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07046234":3,"trial-entities:NCT07046234":112,"trial-summary:NCT07046234":117},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":40,"secondary_outcomes":47,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":14,"eligibility_criteria":70,"std_ages":80,"locations":83,"central_contacts":108,"overall_officials":109,"references":110,"see_also_links":111},"NCT07046234","SA-000147","Point of Care Lung Ultrasound Examination in Patients With Shortness of Breath","ENROLLING_BY_INVITATION","2025-12","2025-09","2025-10-03","2025-08-19","GE Healthcare","INDUSTRY",false,"This is a prospective, non-randomized clinical validation research study. Subjects will consent and have two ultrasounds as part of the study.","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.",[18,19],"Lung Disease","Lung Ultrasound",[19,21],"Artificial Intelligence","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[25],"NA",{"count":27,"type":28},150,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":38},"DEVICE","Lung ultrasound","Lung ultrasound software.",[35,36,37],"Cohort 0 - Vscan (no AI)","Cohort 1 -Device 1","Cohort 2 -Device 2",[39],"SaMD",[41,45],{"measure":42,"description":43,"timeFrame":44},"Cohort 1: % of patient studies composed of images acquired by the THCPs with sufficient quality to make a clinical assessment","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.","7 months",{"measure":46,"description":43,"timeFrame":44},"Cohort 2: % of patient studies composed of images acquired by the Qualified user to make a clinical assessment",[48,51,54,56,58,61,63,65],{"measure":49,"description":50,"timeFrame":44},"Cohort 1:","Sub-group analyses will be performed on the diagnostic image quality performance, with descriptive statistics reported based on age (\\\u003C 65, ≥ 65), BMI group (\\\u003C 25, 25 ≤ BMI \\\u003C 30, ≥ 30), gender (Male \u002F 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":52,"description":53,"timeFrame":44},"Cohort 2:","Sub-group analyses will be performed on the diagnostic image quality performance, with descriptive statistics reported based on age (\\\u003C 65, ≥ 65), BMI group (\\\u003C 25, 25 ≤ BMI \\\u003C 30, ≥ 30), gender (Male \u002F 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":49,"description":55,"timeFrame":44},"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 \u002F Consolidation, Lung Sliding).",{"measure":52,"description":57,"timeFrame":44},"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 \u002F Consolidation, Lung Sliding).",{"measure":59,"description":60,"timeFrame":44},"Cohort 1 and 2:","Recording mode (% of clips acquired with auto-capture rate versus save best clip).",{"measure":49,"description":62,"timeFrame":44},"Acquisition time to complete the LUS exam and for each view (1 - 8).",{"measure":52,"description":64,"timeFrame":44},"Acquisition time to complete the LUS exam and for each view (1 - 12).",{"measure":59,"description":66,"timeFrame":44},"Inter-rater (physician image-interpretation) variability.","ALL","22 Years",null,{"inclusion":71,"exclusion":74,"raw_text":79},[72,73],"1\\. Patients over the age of 22; AND","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.",[75,76,77,78],"1\\. Patients in extremis and\u002For patients in whom a lung ultrasound would not normally be performed;","2\\. Patients who are unable to consent;","3\\. Patients who are prisoners; AND","4\\. Patients who do not speak English fluently.","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\u002For 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.",[81,82],"ADULT","OLDER_ADULT",[84,93,101],{"facility":85,"city":86,"state":87,"zip":88,"country":89,"geoPoint":90},"Yale University School of Medicine","New Haven","Connecticut","06511","United States",{"lat":91,"lon":92},41.30815,-72.92816,{"facility":94,"city":95,"state":96,"zip":97,"country":89,"geoPoint":98},"Rush University Medical Center","Chicago","Illinois","60612-3833",{"lat":99,"lon":100},41.85003,-87.65005,{"facility":102,"city":103,"state":96,"zip":104,"country":89,"geoPoint":105},"Northwestern University","Evanston","60208",{"lat":106,"lon":107},42.04114,-87.69006,[],[],[],[],{"nct_id":4,"conditions":113,"biomarkers":116},[114,115],"Dyspnea","Lung Disorder",[],{"nct_id":4,"found":14,"summary":69,"prompt_version":69}]