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| Name | Class |
|---|---|
| Northwestern University | OTHER |
| Rush University Medical Center | OTHER |
| Yale University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 -Device 1 | Experimental | 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. The 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). The Expert LUS user will use the same ultrasound system but without Caption Lung AI (Control Exam). |
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| Cohort 2 -Device 2 | Experimental | Cohort 2 will utilize the Venue GO ultrasound system to perform a 12-zone lung ultrasound (LUS) exam. All 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). The Qualified user will use the same ultrasound system but without Caption Lung AI (Control Exam). |
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| Cohort 0 - Vscan (no AI) | Active Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung ultrasound | Device | Lung ultrasound software. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Cohort 2: % of patient studies composed of images acquired by the Qualified user 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 | Description | Time Frame |
|---|---|---|
| Cohort 1: | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06511 | United States | ||
| Rush University Medical Center |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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| 7 months |
| Cohort 2: | 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. | 7 months |
| Cohort 1: | Task-based comparison of the study and control exams: o 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). | 7 months |
| Cohort 2: | Task-based comparison of the study and control exams: o 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). | 7 months |
| Cohort 1 and 2: | Recording mode (% of clips acquired with auto-capture rate versus save best clip). | 7 months |
| Cohort 1: | Acquisition time to complete the LUS exam and for each view (1 - 8). | 7 months |
| Cohort 2: | Acquisition time to complete the LUS exam and for each view (1 - 12). | 7 months |
| Cohort 1 and 2: | Inter-rater (physician image-interpretation) variability. | 7 months |
| Chicago |
| Illinois |
| 60612-3833 |
| United States |
| Northwestern University | Evanston | Illinois | 60208 | United States |