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Clinical Validity Verification on Diagnostic Assistance for Presence and Severity of Colorectal Cancer and Polyps Using Artificial Intelligence-based Medical Device Software Endoscopic Imaging Assistance

2026年8月2日更新者：Ainex Corporation

Clinical Validity Verification on Diagnostic Assistance for Presence and Severity of Colorectal Cancer and Polyps Using Artificial Intelligence-Based Medical Device Software for Endoscopic Imaging Assistance: A Single-Center, Single-Arm, Retrospective, Confirmatory Clinical Trial

This completed retrospective study evaluated the clinical performance of ENAD-CADx-01, an artificial intelligence-based medical device software intended to assist healthcare professionals in characterizing colorectal lesions in colonoscopy images. Previously collected colonoscopy images and corresponding histopathological results from Asan Medical Center were analyzed. The performance of ENAD-CADx-01 was evaluated based on its sensitivity, specificity, and overall accuracy in classifying colorectal lesions as neoplasm, hyperplastic polyp, or sessile serrated lesion. No participants were prospectively enrolled, and no study-related intervention was performed.

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

1114

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

韩国
- Seoul
  - Seoul、Seoul、韩国、05505
    - Asan Medical Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

The study population consisted of adults aged 18 years or older who underwent colonoscopy at Asan Medical Center and had previously collected colonoscopy images of colorectal lesions with corresponding histopathological results. Eligible images were retrospectively analyzed to evaluate the clinical performance of ENAD-CADx-01 in classifying lesions as neoplasm, hyperplastic polyp, or sessile serrated lesion.

描述

Inclusion Criteria:

Participants aged 18 years or older at the time of colonoscopy.
Participants who underwent colonoscopy at Asan Medical Center and had colorectal lesion images available for retrospective analysis.
Participants with corresponding histopathological results available as the reference standard.
Colonoscopy images that met the predefined image quality requirements for analysis by ENAD-CADx-01.

Exclusion Criteria:

Participants without corresponding histopathological results for the colorectal lesion.
Images with insufficient quality for analysis, including severe blur, obstruction, or inadequate visualization of the lesion.
Images or records with missing or insufficient data required for the clinical performance analysis.
Lesions that did not meet the predefined target lesion categories or other eligibility requirements specified in the clinical investigation plan.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量	大体时间
Clinical Sensitivity for Neoplasm 大体时间：Up to 4 weeks	Up to 4 weeks
Clinical Specificity for Neoplasm 大体时间：Up to 4 weeks	Up to 4 weeks
Clinical Sensitivity for Hyperplastic Polyps 大体时间：Up to 4 weeks	Up to 4 weeks
Clinical Specificity for Hyperplastic Polyps 大体时间：Up to 4 weeks	Up to 4 weeks
Clinical Sensitivity for Sessile Serrated Lesions 大体时间：Up to 4 weeks	Up to 4 weeks
Clinical Specificity for Sessile Serrated Lesions 大体时间：Up to 4 weeks	Up to 4 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ainex Corporation

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年1月20日

初级完成 (实际的)

2025年2月17日

研究完成 (实际的)

2025年2月17日

研究注册日期

首次提交

2026年7月29日

首先提交符合 QC 标准的

2026年8月2日

首次发布 (实际的)

2026年8月4日

研究记录更新

最后更新发布 (实际的)