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临床试验/NCT05594485
NCT05594485已完成不适用

Chest X-Ray Abnormality Detection Using Artificial Intelligence: Retrospective Study of Carebot AI CXR Performance in Preclinical Practice

Carebot s.r.o.1 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2022年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
127
试验地点
1
主要终点
Primary objective

研究概览

简要总结

The purpose of this study is to describe the design, methodology and evaluation of the preclinical test of Carebot AI CXR software, and to provide evidence that the investigated medical device meets user requirements in accordance with its intended use. Carebot AI CXR is defined as a recommendation system (classification "prediction") based on computer-aided detection. The software can be used in a preclinical deployment at a selected site before interpretation (prioritization, display of all results and heatmaps) or after interpretation (verification of findings) of CXR images, and in accordance with the manufacturer's recommendations. Given this, a retrospective study is performed to test the clinical effectiveness on existing CXRs.

详细描述

The performance of the trained and internally validated Carebot AI CXR software is tested on a set of 127 CXR images from target population. This is compared to common clinical practice, i.e., image assessment by a radiologist in a hospital. Patients may have a variety of findings; at this stage of the evaluation, an abnormal finding is considered to be an abnormality in any of the defined classes. False negative images incorrectly predicted by Carebot AI CXR software result in a clinical impact determination.

To collect the CXR data for retrospective study, investigators addressed a municipal hospital in the Czech Republic that provides healthcare services to up to 130,000 residents of a medium-sized city (approximately 70,000 inhabitants) and the surrounding area. 127 anonymized CXR images were collected between August 15 and 17, 2022, and subsequently submitted to five independent radiologists of varying experience for annotation. The selected radiologists were asked to assess whether the CXR image shows any of the 12 pre-selected abnormalities. Pediatric CXR images (under 18 years of age), scans with technical problems (poor image quality, rotation), and images in lateral projection were excluded from the dataset.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Hospital patients who were referred for chest radiography between August 15 and 17, 2022.

排除标准

  • Pediatric CXR images (under 18 years of age)
  • Scans with technical problems (poor image quality, rotation)
  • Images in lateral projection

结局指标

主要结局

Primary objective

时间窗: 20-10-2022

Comparison of the accuracy of radiologist and Carebot AI CXR image assessment.

次要结局

  • Secondary objective(20-10-2022)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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