Prospective, multicenter, self-controlled clinical trial on the effectiveness and safety of a cable-transmission magnetically controlled capsule endoscopy system for the examination of upper GI diseases.

ABSTRACT

BACKGROUND AND AIMS: Many GI disorders and precancerous conditions often present asymptomatically, leading to delayed patient diagnoses and treatment interventions. In this study, we developed a novel cable-transmission magnetically controlled capsule endoscopy (CT-MCCE) system for detecting GI diseases and assessed its safety and feasibility through clinical trials. METHODS: This prospective, multicenter trial compared CT-MCCE with conventional gastroscopy in patients aged 18 to 75 years with upper GI tract diseases between October 2022 and July 2023. The primary endpoints were the evaluation of sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) in the detection of focal lesions within the esophagus, stomach, and duodenal bulb using CT-MCCE. RESULTS: One hundred eighty individuals (mean age, 43.1 years; 52.22% women) were recruited from 3 hospitals in China. CT-MCCE detected lesions in the esophagus with a sensitivity of 97.22%, specificity of 100%, PPV of 100%, NPV of 98.18%, and accuracy of 98.89%; detected gastric focal lesions in the entire stomach with a sensitivity of 96.81%, specificity of 98.84%, PPV of 98.91%, NPV of 96.59%, and accuracy of 97.78%; and detected lesions in the duodenal bulb with a sensitivity of 100%, specificity of 100%, PPV of 100%, NPV of 100%, and accuracy of 100%. There were no significant differences between CT-MCCE and EGD regarding the cleanliness of the upper GI tract and visibility of the upper GI mucosa. However, CT-MCCE was associated with a lower incidence of discomfort than EGD (P < .001). CONCLUSIONS: The diagnostic performance of CT-MCCE is comparable with that of EGD in the completion of upper GI tract examinations and lesion detection. Furthermore, the improved tolerance of CT-MCCE in detecting upper GI diseases was noted without any observed adverse events. (Clinical trial registration number ChiCTR2200063630.).