Remote magnetic control of a wireless capsule endoscope in the esophagus is safe and feasible: results of a randomized, clinical trial in healthy volunteers.
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.
Keller
Jutta
J
Department of Internal Medicine, Israelitic Hospital, Academic Hospital, University of Hamburg, Germany. keller@ik-h.de
Fibbe
Christiane
C
Volke
Frank
F
Gerber
Jeremy
J
Mosse
Alexander C
AC
Reimann-Zawadzki
Meike
M
Rabinovitz
Elisha
E
Layer
Peter
P
Swain
Paul
P
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