Remote magnetic control of a wireless capsule endoscope in the esophagus is safe and feasible: results of a randomized, clinical trial in healthy volunteers

BackgroundRemote control of esophageal capsule endoscopes could enhance diagnostic accuracy.ObjectiveTo 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.DesignRandomized, controlled trial.SettingAcademic hospital.PatientsThis study involved 10 healthy volunteers.InterventionAll 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 MeasurementsSafety and tolerability of the procedure (questionnaire), responsiveness of the MMC to the EMP, esophageal transit time, and visualization of the Z-line.ResultsNo 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).LimitationsMagnetic forces were not strong enough to hold the MMC against peristalsis when the capsule approached the gastroesophageal junction.ConclusionRemote 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.)