许多胃肠道 (GI) 疾病和癌前病变通常无症状，导致患者诊断和治疗干预延迟。本研究旨在开发一种新型电缆传输磁控胶囊内窥镜（CT-MCCE）系统，用于检测胃肠道疾病，并通过临床试验评估其安全性和可行性。这项前瞻性、多中心试验将 CT-MCCE 与传统胃镜检查在老年患者中进行比较2022 年 10 月至 2023 年 5 月期间患有上消化道疾病的 18-75 岁患者。主要终点包括评估食管内局灶性病变检测的敏感性、特异性、阳性预测值 (PPV) 和阴性预测值 (NPV)，使用CT-MCCE对胃和十二指肠球进行检查。从中国三家医院招募了总共180名受试者（平均年龄：43.1岁，52.22％女性）。 CT-MCCE 检测食管病变的灵敏度为 97.22%，特异性为 100%，PPV 为 100%，NPV 为 98.18%，准确度为 98.89%。 CT-MCCE检测全胃局灶性病变，敏感性为96.81%，特异性为98.84%，PPV为98.91%，NPV为96.59%，准确度为97.78%。 CT-MCCE 检测十二指肠球部病变的敏感性为 100%，特异性为 100%，PPV 为 100%，NPV 为 100%，准确性为 100%。 CT-MCCE 和 EGD 在上消化道清洁度和上消化道粘膜可见度方面没有显着差异。然而，CT-MCCE 的不适发生率低于 EGD（P<0.001）。在完成上消化道检查和病变检测方面，CT-MCCE 的诊断性能与 EGD 相当。此外，CT-MCCE 在检测上消化道疾病方面的耐受性得到改善，且未观察到任何不良事件。版权所有 © 2024 美国胃肠内窥镜协会。由爱思唯尔公司出版。保留所有权利。

Many gastrointestinal (GI) disorders and precancerous conditions often present asymptomatically, leading to delayed patient diagnoses and treatment interventions. This study aimed to develop a novel cable-transmission magnetically controlled capsule endoscopy (CT-MCCE) system for detecting GI diseases and assess its safety and feasibility through clinical trials.This prospective, multicenter, trial compared CT-MCCE with conventional gastroscopy in patients aged 18-75 years with upper GI diseases between October 2022 and May 2023. The primary endpoints included 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.A total of 180 individuals (mean age: 43.1 years, 52.22% female) were recruited from three hospitals in China. CT-MCCE detected lesions in esophagus with 97.22% sensitivity, 100% specificity, a PPV of 100%, a NPV of 98.18%, and 98.89% accuracy. CT-MCCE detected gastric focal lesions in the whole stomach with 96.81% sensitivity, 98.84% specificity, a PPV of 98.91%, a NPV of 96.59%, and 97.78% accuracy. CT-MCCE detected lesions in the duodenal bulb with 100% sensitivity, 100% specificity, a PPV of 100%, a NPV of 100%, and 100% accuracy. 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<0.001).The diagnostic performance of CT-MCCE is comparable to 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.Copyright © 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.