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临床试验/NCT05020262
NCT05020262Unknown不适用

A Retrospective, Single-center, Readerblind, Nonrandomized Clinical Trial Was Conducted to Evaluate the Function of Incisive CT Precise Image and Precise Cardiac Function

Philips Healthcare (Suzhou) Co., Ltd.0 个研究点目标入组 112 人开始时间: 2021年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
112
主要终点
The quality of PI/PC and iDose4/ cardiac imaging reconstructed images was basically equal or above 3 score

研究概览

简要总结

The purpose of this study was to evaluate whether the new features of Incisive CT: Precise Image, (PI) and Precise Cardiac (PC) had the expected effectiveness

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The original data of the images are from the patient base in the age range of 18 to 75 years (18≤ age ≤75 years)
  • Original image data are collected in Incisive CT (version 4.5) and traceable;
  • Time range for inclusion of original image data: from the start of the clinical trial to the completion of collection in compliance with this protocol;

排除标准

  • The investigator deemed it inappropriate to include the original image data for this clinical trial

结局指标

主要结局

The quality of PI/PC and iDose4/ cardiac imaging reconstructed images was basically equal or above 3 score

时间窗: through study completion, an average of 2months

Scoring criteria 5 points The image quality of PI/PC is better than that of iDose4/ cardiac imaging, which can be used for diagnosis, very satisfied 4 points The image quality of PI/PC is better than that of contrast products, and the image of iDose4/ cardiac imaging can be used for diagnosis, satisfactory 3 points The image quality of PI/PC is basically equivalent to that of iDose4/ cardiac imaging. The image quality is defective, which does not affect the diagnosis, but is normal 2. The image quality of PI/PC is not lower than iDose4/ cardiac imaging, but the image quality is poor, which affects the diagnosis and is not satisfactory 1 points The image quality is lower than iDose4/ cardiac imaging after using PI/PC, the image quality is poor, cannot diagnose, unsatisfactory

次要结局

  • Imaging reconstruction clarity using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score(through study completion, an average of 2months)
  • Imaging reconstruction Noise level using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score(through study completion, an average of 2months)
  • Imaging reconstruction enhancement condition using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score(through study completion, an average of 2months)
  • Imaging reconstruction diagnostic confidence using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score(through study completion, an average of 2months)
  • Imaging reconstruction Image texture using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score(through study completion, an average of 2months)
  • Imaging reconstruction Image artifacts using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score(through study completion, an average of 2months)

研究者

发起方
Philips Healthcare (Suzhou) Co., Ltd.
申办方类型
Industry
责任方
Sponsor

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