Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Prismatic Sensors AB | UNKNOWN |
Not provided
Not provided
Not provided
The purpose of the study is to collect data to evaluate feasibility of the using photon-counting CT in a clinical setting.
Data collected in this study includes an assessment of image quality parameters including spatial resolution, image contrast, and noise that will evaluate the product and how this photon-counting CT technology can be used to reduce the overall radiation dose in CT imaging, and enhance clinical applications for CT technology.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subject's Scanned with Investigational Device | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT with a photon-counting detector | Device | Enrolled subjects will complete an exam using the photon-counting CT, with or without IV contract as indicated. Images will then be compared with the previously acquired CT conducted as standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate feasibility of the photon-counting CT in a clinical setting. | The primary objective of this study is to collect and evaluate raw CT scan data collected using the photon-counting CT. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Collect feedback on performance and images generated on the photon-counting CT. | Gather feedback on the performance and image quality of the reconstructed images produced by using the photon-counting CT. | 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Melissa Challman | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | 17164 | Sweden |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The single group model will enroll subjects from 5 anatomical areas (lungs, brain/carotid vessels, heart/chest, MSK and abdomen) where CT imaging is applicable and where data on the photon-counting CT is needed to assess feasibility and guide further development of the technology.
Not provided
Not provided
Not provided
Not provided