Clinical Study for Precise Image for Musculoskeletal CT for Incisive CT and CT 5300 Systems
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 84
- 主要终点
- Assessment of CT Image quality and diagnostic confidence of Precise Image via 5-point Likert Scale
研究概览
简要总结
The purpose of this clinical study is to evaluate the performance of the Precise Image reconstruction algorithm for musculoskeletal CT imaging (shoulder, hip, knee) of adult patients (>18 years old). 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 and diagnostic acceptability of Precise Image compared to the standard-of-care reference (iDose4) for:
o Musculoskeletal CT images (shoulder, hip, knee) of adult patients (>18 years old). 2. To demonstrate non-inferiority of Precise Image to iDose4 for the planned resolution groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects scanned by FDA-cleared and marketed Philips Incisive CT or CT 5300 systems, and according to the department standard of care clinical protocols for the applicable anatomies.
- •Subject age: Above 18 years old.
排除标准
- •Subject age: 18 years old and below.
- •Scans that were acquired using generic 'Body' scan type (as Precise Image does not support generic 'Body' scan types).
- •Scans that were acquired using a kilovoltage peak of 70 kVp (as Precise Image does not support a kilovoltage peak lower than 80 kVp).
- •Scans that the site radiologists have deemed as non-diagnostic image quality in standard practice (e.g. patient movement).
- •Scans that failed internal technical checks (e.g., corrupt files, failure to reconstruct).
结局指标
主要结局
Assessment of CT Image quality and diagnostic confidence of Precise Image via 5-point Likert Scale
时间窗: Reading session at 4 months
The image quality and diagnostic acceptability of Precise Image reconstructions are at least as good as (non-inferior to) iDose4 reconstructions for musculoskeletal CT images (shoulder, hip, knee) of adult patients (\>18 years old). Measurement will be done via 5-point Likert Scale for Image Quality where 5 is excellent and 1 is poor image quality.
次要结局
未报告次要终点