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临床试验/NCT05282056
NCT05282056已完成不适用

COVID-19 Volumetric Quantification on Computer Tomography Using Computer Aided Diagnostics

Bogdan Bercean1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年2月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Mean difference of lung affection quantification percentage

研究概览

简要总结

The aim of the study is to asses the influence of computer aided diagnostic to the process of lung affection quantification on computer tomography in COVID-19 confirmed patients.

详细描述

The lung involvement of COVID-19 patients has been showed to be correlated to clinical outcomes and became part of the clinical practice. Even though various scores can be used, the affection estimation is usually done on computer tomography, using radiologists's estimation skills which is a highly subjective process.

Artificial intelligence is a known objective constant and therefore a potential radiologist complement. This trial aims at studying the effect of using a computer aided diagnostic software integrated in the normal clinical practice of radiologists from Timisoara County Emergency Hospital. It uses the AI-PROBE analysis setup, which turns off the CAD outputs for randomly chosen 50% the cases (control) and then compares the radiological reports for differences between the two arms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

盲法说明

The random assignment is done automatically by the CAD system and is not visible to the patient. The radiologist obviously sees which cases have CAD analysis and which not.

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • RT-PCR confirmed patients of COVID-19

排除标准

  • 15 or lower

结局指标

主要结局

Mean difference of lung affection quantification percentage

时间窗: At CT acquisition time, up to 2 weeks

The objective measurement of lung affection percentage is measured against pixel level labels. A lower difference mean better outcome.

次要结局

未报告次要终点

研究者

发起方
Bogdan Bercean
申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

Bogdan Bercean

Head of Artificial Intelligence

XVision

研究点 (1)

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