Lung; Node
Conditions
Brief summary
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.
Interventions
DEVICEVeye Lung nodules
Veye Lung Nodules
Sponsors
Aidence
Study design
Observational model
CASE_CROSSOVER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
\- Subjects that underwent a CT chest scan for either lung cancer screening or routine practice
Exclusion criteria
* Subjects with \>10 pulmonary nodules; * Subjects with pulmonary mass(es) = largest axial diameter \>30mm; * Subjects with interstitial lung disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection accuracy | 2 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Segmentation accuracy | 1 month | Demonstrate that the accuracy for segmenting actionable pulmonary nodules by the device is non-inferior to expert radiologists |
Other
| Measure | Time frame | Description |
|---|---|---|
| Growth assessment accuracy | 1 month | Demonstrate that the accuracy for determining volume change of actionable pulmonary nodules by the device is non-inferior to expert radiologists |
| Composition classification accuracy | 2 months | 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) |
Countries
United States
Contacts
Primary ContactJoris Wakkie, Ms
Outcome results
None listed