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| Name | Class |
|---|---|
| Philips Healthcare (Suzhou) Co., Ltd. | INDUSTRY |
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The purpose of this clinical trial is to evaluate the efficacy and safety of the CT 5400 RT System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Image quality performance | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT 5400 RT System | Diagnostic Test | Computed Tomography X-RAY System is intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical image quality | Image quality will be assessed by Likert score (1-5) | 14 days (anticipated) |
| Measure | Description | Time Frame |
|---|---|---|
| General function assessment | A three-scale assessment will be used for Image exposure level, couch movement, speaker& microphone voice quality, image post processing capability, data storage. A three-scale criteria- Very satisfied, Satisfied, Dissatisfied Assessment criteria: all parameters will be assessed based on the user's feelings. The parameters should all reach "Satisfied", indicating that the general function of the case meet the clinical application requirements. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Public Health Clinical Center | Shanghai | Shanghai Municipality | 200120 | China |
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| 14 days (anticipated) |
| Convenience assessment | A three-scale assessment will be used for laser positioning, panel control, user-friendly interface of post-processing software, operation of post-processing software. A three-scale criteria- Very satisfied, Satisfied, Dissatisfied Assessment criteria: all parameters will be assessed based on the user's feelings. The parameters should all reach "Satisfied", indicating that the general function of the case meet the clinical application requirements. | 14 days (anticipated) |
| Workflow and stability assessment | A three-scale assessment will be used for workflow, Image display and transmission, system inactivation, unexpected system shutdown, unexpected termination during scanning, fail to expose during scanning A three-scale criteria- Very satisfied, Satisfied, Dissatisfied Assessment criteria: all parameters will be assessed based on the user's feelings. The parameters should all reach "Satisfied", indicating that the general function of the case meet the clinical application requirements. | 14 days (anticipated) |
| Incidence of CT Scan-Emergent Adverse Events | Monitor adverse events and serious adverse events(safety and tolerance) during the study | 30 days (anticipated) |