Solitary Pulmonary Nodules Clinical Trial
Official title:
Clinical Evaluation of CARESTREAM Dual Energy and Digital Tomosynthesis
The purpose of this study is to evaluate the imaging performance of Dual Energy and Digital Tomosynthesis (DE-DT) application against the commercially available predicate devices.
The acquisition system will consist of using site equipment including the CARESTREAM
DRX-Evolution x-ray system, and the predicate CARESTREAM DRX Plus detector and the
investigational DE-DT application.
DE Study Design Thirty to forty (30-40) patients will receive a DR standard of care chest
exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy
and low energy image exposures using the investigational device. These images are used by
the DE console software to generate additional DE images (e.g. bone and soft tissue).
DT Study Design Fifteen to twenty (15-20) patients will receive a DR standard of care chest
exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image
(chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT
console software to generate tomographic images.
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Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
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