Magnetically controlled capsule for assessment of the gastric mucosa in symptomatic patients: a prospective, single-arm, single-center, comparative study.

Background and Aims: Magnetically controlled capsule endoscopy (MCCE) has the potential to allow an operator to move a video capsule endoscope inside the foregut. The primary objective of this pilot study was to demonstrate that MCCE could visualize the major anatomic regions of the stomach in symptomatic patients before an EGD. Secondary objectives were measuring patient satisfaction, patient safety, and comparing MCCE with a follow-up EGD in the detection of any significant gastric lesions. Methods: In this prospective, single-arm, single-center, comparative study, adult patients aged ≥18 years who were referred for an EGD as part of a standard evaluation for symptoms were approached for participation in the study. Participants received MCCE before the EGD. MCCE videos were reviewed by 2 independent physicians and compared with subsequent EGD. Patients were followed for 30 days for safety outcomes and satisfaction. Results: In this study of 40 patients, MCCE detected each of the 6 preidentified major gastric anatomic landmarks with a greater than 95% rate of visualization. Thirty-five patients received a follow-up EGD, and no high-risk lesions were missed with MCCE. Patients preferred MCCE to EGD (80%-13%), and there were no adverse events. Conclusions: In the first pilot study of MCCE in the United States, a high rate of visualization of all regions of the gastric mucosa was achieved. In addition, high satisfaction and no adverse events were recorded. Future studies will focus on higher-risk cohorts to confirm the accuracy of detection of benign, premalignant, and malignant gastric lesions.