Eligible participants were aged 18–80 years with suspected gastric pathology and no previous surgery. Participants underwent FAMCE for screening of gastric lesions, then conventional transoral gastroscopy 2 h later, and stomach examination results were compared. The primary outcome was the rate of complete detection of gastric anatomy landmarks (cardia, fundus, body, angulus, antrum, and pylorus)by FAMCE. Secondary outcomes were the time required for gastric completion by FAMCE, the rate of detection of gastric lesions by FAMCE compared with conventional transoral gastroscopy, and the rate of complete small bowelexamination. Adverse events were also evaluated.
在18-80岁之间，选择符合条件的参与者，疑似胃部病变且既往未接受过手术。参与者先行RC100筛查胃部病变，2小时后进行常规经口胃镜检查，比较胃部检查结果。主要结果是RC100 对胃剖解标志（贲门、胃底、身体、胃角、胃窦和幽门）的完全检测率。次要结果是RC100 完成胃部检查所需的时间、RC100 与传统经口胃镜检查相比对胃病变的检出率以及小肠完全检查率。