NCT05470452Unknown不适用
Validating the Safety and Effectiveness of ENDOANGEL Upper Gastrointestinal Endoscope Image Auxiliary Diagnostic Software
The Second Affiliated Hospital of Chongqing Medical University1 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2021年7月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- AFROC-AUC
研究概览
简要总结
The upper Gastrointestinal Endoscope Image Auxiliary Diagnostic Software developed by Wuhan ENDOANGEL Medical Technology Co., Ltd. is used for the identification of gastric cancer in endoscopic magnification mode in definitive images to assist in the diagnosis of upper gastrointestinal gastric cancer lesions. The aim of this study is to evaluate the safety and effectiveness of the software in clinical use.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18, male or female；
- •Cases with complete, clear imaging data, including images under white light and magnified stained images；
- •Complete pathological diagnosis of upper digestive tract lesions;
- •The included cases were excluded from the software development.
排除标准
- •Cases whose image data did not meet the evaluation requirements;
- •The investigator considered the case unsuitable for the clinical trial.
结局指标
主要结局
AFROC-AUC
时间窗: 3 months
AFROC-AUC at the level of identified lesions in the upper gastrointestinal cancers in the trial and control groups, using a between-group comparison.
次要结局
- Cancer identification Sensitivity(3 months)
- Cancer Identification Diagnosis Compliance Rate(3 months)
- Cancer identification specificity(3 months)
研究者
研究点 (1)
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