Clinical Study for Precise Image for Interventional 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
- 55
- 主要终点
- Assessment of the CT image quality of Precise Image reconstructions via a 5-point Likert Scale
研究概览
简要总结
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 of Precise Image compared to the standard-of-care reference (iDose4) for:
o Interventional CT images of adult patients (>18 years old). 2. To demonstrate non-inferiority of Precise Image to iDose4 for the relevant interventional CT images.
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 clinical scans.
- •Subject age: >18 years old.
- •Presence of procedural instrument(s) (e.g., needle, probe, screw) in the CT images.
排除标准
- •Subject age: 18 years old and below.
- •Absence of procedural instrument(s) (e.g., needle, probe, screw) in the CT images.
- •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 interventional radiologists have deemed non-suitable for procedural guidance.
- •Scans that the site interventional radiologists have deemed non-suitable for procedural guidance.
结局指标
主要结局
Assessment of the CT image quality of Precise Image reconstructions via a 5-point Likert Scale
时间窗: Reading session at 4 months
The image quality of Precise Image reconstructions will be considered at least as good as (non-inferior to) that of iDose4 reconstructions for interventional CT images (CCT single, continuous, fluoro) of adult patients (\>18 years old)
次要结局
未报告次要终点