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Veye Lung Nodules (Aidence B.V., Amsterdam, the Netherlands) is a medical software device that is intended to assist radiologists with pulmonary nodule management on CT chest scans.
This clinical trial aims to assess the clinical performance of Veye Lung nodules via a standalone performance evaluation and a reader study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Intervention is the use of Veye Lung Nodules during the reading of the CT scans |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Veye Lung nodules | Device | Veye Lung Nodules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detection accuracy | Demonstrate that the accuracy for detecting actionable pulmonary nodules by radiologists using the device (AIDED) is superior to that of radiologists not using the device (UNAIDED) | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Segmentation accuracy | Demonstrate that the accuracy for segmenting actionable pulmonary nodules by the device is non-inferior to expert radiologists | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Growth assessment accuracy | Demonstrate that the accuracy for determining volume change of actionable pulmonary nodules by the device is non-inferior to expert radiologists | 1 month |
| Composition classification accuracy |
Inclusion Criteria:
- Subjects that underwent a CT chest scan for either lung cancer screening or routine practice
Exclusion Criteria:
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US adult population that received a CT chest scan either as part of a lung cancer screening program or during routine practice
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joris Wakkie, Ms | Contact | +31624561754 | joris@aidence.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intrinsic Imaging | Recruiting | Boston | Massachusetts | 01740 | United States |
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Demonstrate that the accuracy for classifying the composition of actionable pulmonary nodules by radiologists using the device (AIDED) is superior to that of radiologists not using the device (UNAIDED)
| 2 months |