title: Remote magnetic control of a wireless capsule endoscope in the esophagus is safe and feasible: 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.
  
  
  METHODS
  Randomized, controlled trial.
  
  
  METHODS
  Academic hospital.
  
  
  METHODS
  This study involved 10 healthy volunteers.
  
  
  METHODS
  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.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  Magnetic forces were not strong enough to hold the MMC against peristalsis when the capsule approached the gastroesophageal junction.
  
  
  CONCLUSIONS
  Remote control of the MMC in the esophagus of healthy volunteers is safe and feasible, but higher magnetic forces may be needed.
authors.affiliation: Department of Internal Medicine, Israelitic Hospital, Academic Hospital, University of Hamburg, Germany. keller@ik-h.de
authors.forename: Jutta
authors.initials: J
authors.lastname: Keller
authors.forename: Christiane
authors.initials: C
authors.lastname: Fibbe
authors.forename: Frank
authors.initials: F
authors.lastname: Volke
authors.forename: Jeremy
authors.initials: J
authors.lastname: Gerber
authors.forename: Alexander C
authors.initials: AC
authors.lastname: Mosse
authors.forename: Meike
authors.initials: M
authors.lastname: Reimann-Zawadzki
authors.forename: Elisha
authors.initials: E
authors.lastname: Rabinovitz
authors.forename: Peter
authors.initials: P
authors.lastname: Layer
authors.forename: Paul
authors.initials: P
authors.lastname: Swain
mesh_terms: D000328:Adult; D053705:Capsule Endoscopes; D053704:Capsule Endoscopy / Q000295:instrumentation*; D004867:Equipment Design; D004869:Equipment Safety; D004947:Esophagus / Q000033:anatomy & histology / Q000502:physiology; D005240:Feasibility Studies; D005260:Female; D005772:Gastrointestinal Transit / Q000502:physiology; D006801:Humans; D008280:Magnetics; D008297:Male; D015203:Reproducibility of Results; D055815:Young Adult