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| Name | Class |
|---|---|
| University of Wisconsin, Madison | OTHER |
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The purpose of the study is to collect data to evaluate utility of a next generation CT system in a clinical setting.
Data collected in this study includes an assessment of image quality parameters including spatial resolution, image contrast, and noise to evaluate the product. This data and analysis will help support regulatory submission.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General | Approximately 80 subjects whose standard of care imaging involved the head/neck, chest, abdomen/bowel and/or musculoskeletal regions will be enrolled. |
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| Cardiac | Approximately 20 subjects whose standard of care imaging involved the heart will be enrolled. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational CT Scan | Device | All pre-contrast testing and administration of supporting medications shall be done according to the hospital's SOC. Images will then be compared with the previously acquired imaging conducted as standard of care. The investigational scan takes between 10-30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Data Collection | Number of investigational CT scans along with standard of care CT images | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Information | Type and numbers of AEs, SAEs, and Device Deficiencies | 12 months |
| Assessment of Image Quality | Images created from the raw investigational CT scan data will be scored for image quality |
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Inclusion Criteria:
Subjects may be included in this study if they meet the following criteria:
Exclusion Criteria:
Subjects may be excluded from participating in study if they meet any of the following criteria:
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The subject population will consist of adults that are 18-years of age or older, and who have undergone a prior clinically indicated imaging exam of at least one of the following anatomical areas: head, neck, heart, chest, abdomen, pelvis, and/or extremities.
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| Name | Affiliation | Role |
|---|---|---|
| MICT Global Research Manager | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin, Madison | Madison | Wisconsin | 53792 | United States |
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| 12 months |