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| Name | Class |
|---|---|
| Philips Healthcare (Suzhou) Co., Ltd. | INDUSTRY |
The purpose of this clinical study is to assess the performance of the Precise Image reconstruction algorithm on interventional CT images acquired from adult patients (>18 years old). The analysis will focus on the performance of Precise Image for scans in which procedural instruments (e.g., needle, probe, screw) are present. Clinical data generated from this study is intended to support a proposed expansion of the Indications for Use of Precise Image.
The study has two objectives:
To evaluate the image quality for procedural guidance and procedural confidence of Precise Image compared to the standard-of-care reference (iDose4) for:
To demonstrate non-inferiority of Precise Image to iDose4 for the relevant interventional CT images.
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| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the CT image quality of Precise Image reconstructions via a 5-point Likert Scale | The image quality of Precise Image reconstructions is non-inferior to iDose4 reconstructions for interventional CT images of adult patients. Measurement will be done via 5-point Likert Scale for Image Quality where 5 is excellent and 1 is poor image quality. | Reading session at 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adults
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