Results of a randomized, clinical trial in healthy volunteers

Abstract
Background: Remote control of esophageal capsule endoscopes could enhance diagnostic accuracy. Objective: To assess the safety and efficacy of remote magnetic manipulation of a modified capsule endoscope (magnetic maneuverable capsule [MMC]; Given Imaging Ltd, Yoqneam, Israel) in the esophagus of healthy humans. Design: Randomized, controlled trial. Setting: Academic hospital. Patients: This study involved 10 healthy volunteers. Intervention: All participants swallowed a conventional capsule (ESO2; Given Imaging) and a capsule endoscope with magnetic material, the MMC, which is activated by a thermal switch, in random order (1 week apart). An external magnetic paddle (EMP; Given Imaging) was used to manipulate the MMC within the esophageal lumen. MMC responsiveness was evaluated on a screen showing the MMC film in real time. Main Outcome Measurements: Safety and tolerability of the procedure (questionnaire), responsiveness of the MMC to the EMP, esophageal transit time, and visualization of the Z-line. Results: No adverse events occurred apart from mild retrosternal pressure (n = 5). The ability to rotate the MMC around its longitudinal axis and to tilt it by defined movements of the EMP was clearly demonstrated in 9 volunteers. Esophageal transit time was highly variable for both capsules (MMC, 111-1514 seconds; ESO2, 47-1474 seconds), but the MMC stayed longer in the esophagus in 8 participants (P < .01). Visualization of the Z-line was more efficient with the ESO2 (inspection of 73% +/- 18% of the circumference vs 33% +/- 27%, P = .01). Limitations: Magnetic forces were not strong enough to hold the MMC against peristalsis when the capsule approached the gastroesophageal junction. Conclusion: Remote control of the MMC in the esophagus of healthy volunteers is safe and feasible, but higher magnetic forces may be needed. (Clinical trial registration number: DE/CA05/2009031008.) (Gastrointest Endosc 2010;72:941-6.)