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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,114
- 试验地点
- 1
- 主要终点
- Clinical Specificity for Sessile Serrated Lesions
研究概览
简要总结
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
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Clinical Specificity for Sessile Serrated Lesions
时间窗: Up to 4 weeks
Clinical Sensitivity for Neoplasm
时间窗: Up to 4 weeks
Clinical Specificity for Neoplasm
时间窗: Up to 4 weeks
Clinical Sensitivity for Hyperplastic Polyps
时间窗: Up to 4 weeks
Clinical Specificity for Hyperplastic Polyps
时间窗: Up to 4 weeks
Clinical Sensitivity for Sessile Serrated Lesions
时间窗: Up to 4 weeks
次要结局
未报告次要终点