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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-23-01-042048 | Other Identifier | Swedish Medical Products Agency |
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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
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The purpose of the study is to evaluate the investigational Edge-on Silicon Photon Counting CT device in a clinical setting.
Images from prior standard of care diagnostic CT exams for these subjects will also be collected. Data collected in this study will be used for technology development, scientific evaluation, marketing and education, and regulatory submissions for future products. This is a pre-market, prospective, open-label, non-randomized, single arm data collection clinical study conducted at one site in Sweden.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Enrolled subjects will receive a non-diagnostic CT scan on the pre-market, investigational Edge-on Silicon Photon Counting CT device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Edge-on Silicon Photon Counting CT device | Device | Administration of IV contrast material, if applicable, shall be done according to the hospital's SOC. Administration of oral contrast material, if applicable, shall also be done according to the hospital's SOC. Images will then be compared with the previously acquired CT conducted as standard of care. The investigational scan will take approximately 60-120 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Data Collection | Raw investigational CT scan data along with standard of care raw CT scan data/images | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Information | Type and number of AEs and SAEs | 12 months |
| Image Quality | Images created from the raw investigational CT scan data will be scored for image quality using a Likert Scale (1 - Non-Diagnostic to 5 - Excellent Image Quality) |
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Inclusion Criteria:
Exclusion Criteria:
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The subject population will consist of adults that are 25-years of age or older, and who have undergone prior clinically indicated CT examinations within the past 90 days of at least one of the following anatomical area(s): head, neck, heart, chest, abdomen, pelvis, and extremities. Images from prior standard of care diagnostic CT examinations of these subjects will also be collected.
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| Name | Affiliation | Role |
|---|---|---|
| Brian W Thomsen | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Solna | Sweden |
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| 12 months |