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This study is being conducted to collect image data and relevant clinical data from medical records of patients with suspicion of lung consolidation or pleural effusion. The information will be used to test the performance of Artificial Intelligence (AI) in identification of features associated with the above lung conditions.
This is a prospective, observational, multi-center, post-market clinical study. Enrollment will continue (up to a maximum of 500 adult subjects and up to 300 pediatric subjects) until diagnostic LUS exams are acquired for each of the following groups:
Approximately 500 Adult subjects targeting:
Approximately 300 pediatric subjects targeting:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pleural Effusion | Adult and pediatric subjects with suspicion of pleural effusion |
| |
| Lung Consolidation | Adult and pediatric subjects with suspicion of lung consolidation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung Ultrasound Scan | Device | Ultrasound scan of subjects in up to 14 lung zones |
|
| Measure | Description | Time Frame |
|---|---|---|
| The study data will be used to support future performance assessments for Artificial Intelligence based algorithms as described by FDA guidance for Computer Assisted Detection and Diagnostic Devices | Discharge up to 30 days (Single visit) |
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Inclusion Criteria:
Subjects presenting to the Emergency Department, admitted to the hospital, or seen in the outpatient setting with suspicion of pleural effusion or lung consolidation who received chest imaging to include chest X-ray or CT, or for whom chest X-ray or CT are planned.
Suspicion of pleural effusion or lung consolidation may be based upon imaging findings or presentation of symptoms including (but not limited to) dyspnea, hypoxia, tachypnea, rales, or dullness.
All attempts should be made for subjects to undergo scanning of 14 lung zones (adults) and 12 lung zones (pediatrics). Attempts should also be made to capture all required lung zones in adults and pediatrics. Instances where all zones cannot be captured need to be documented and reason for inability to scan them provided in EDC. See Section 8.1.3 Lung Ultrasound Exams.
Subject is willing to provide informed consent (or assent where age appropriate) to participate in the study. Subjects under 18 years of age require informed consent of a parent or guardian and assent as required by institutional IRB.
Weight of subject is greater than or equal to 10 kg.
Exclusion Criteria:
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Adult subjects with suspicion of pleural effusion or lung consolidation will be enrolled in the study. In addition, pediatric subjects with suspicion of lung consolidation (with weight of at least 10 kg) will be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Jochen Kruecker | Philips Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Emergency Medical Research Center | Tucson | Arizona | 85724 | United States | ||
| University of Colorado Hospital |
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| ID | Term |
|---|---|
| D010996 | Pleural Effusion |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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| Aurora |
| Colorado |
| 80045 |
| United States |
| Yale School of Medicine | New Haven | Connecticut | 06510 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Prisma Health Greenville Memorial Hospital | Greenville | South Carolina | 29605 | United States |