Study of the Feasibility of Magnetic Navigated Capsule Endoscope in the Upper Gastrointestinal Tract Examination
Condition: Healthy Patient on Good Condition
Study type: Interventional

Summary: 
      External control of capsule endoscopy (CE) by means of an applied magnetic field is a
      possible way to maneuver the movement of CE in gastrointestinal (GI) tract. The aim of this
      study was to evaluate the safety and feasibility of magnetic maneuvering of a capsule
      endoscope in the upper gastrointestinal tract, including the esophagus, stomach and duodenum
      in healthy subjects.
    

Detailed description: 
      Since their introduction in clinical practice in 2000, capsule endoscopy (CE) have widely
      used as a noninvasive endoscopic examination of the gastrointestinal disorders. Compared with
      traditional endoscopy, CE has had a significant impact in gastroenterology for diagnoses of
      gastrointestinal (GI) diseases, largely owing to the following three reasons. First, wireless
      CE is much more comfortable for the patient. Second, it is much easier and safer to perform.
      Third, it allows visualization of anatomical regions currently precluded to traditional
      endoscopy. However, CE does not allow the operator to control the navigation. The movement of
      the capsule is passive, as it proceeds by means of visceral peristalsis and gravity. This
      makes the movement of the capsule purely random, so that some portions of the
      gastrointestinal surface are unable to be visualized. Moreover, if gastrointestinal lesions
      are identified, the endoscopist cannot maneuver the capsule to perform back and forth, or
      right and left movement to do further detailed observations. All of these factors contribute
      to limit the diagnostic values of CE examination.

      External controllability of CE by means of an applied magnetic field is a possible solution
      to the maneuvering problem. However, there is no effective system with straightforward
      clinical applicability till now. This is ascribable to a lack of reliable magnetic
      instrumentation suitable for such a purpose. We have reported that using magnetic field
      navigator can effectively control the locomotion of CE. We have demonstrated, both in vitro
      and ex vivo, that magnetic field navigator has great potential and practicability of
      achieving high-precision rotation and controllable movement of CE.

      The aim of this study was to evaluate the safety and feasibility of magnetic maneuvering of a
      capsule endoscope in the upper gastrointestinal tract, including the esophagus, stomach and
      duodenum in healthy subjects. The movement of the endoscopic capsule in the esophagus could
      be driven by an external magnetic control device. The external magnetic control device could
      also adjust the direction of movement of the capsule in the stomach and duodenum, which might
      make the examination of the whole upper gastrointestinal tract possible. The magnetic
      navigated CE would enable detailed investigations of the whole upper gastrointestinal tract,
      including the esophagus, stomach and duodenum. Using this remote magnetic manipulation,
      capsule endoscope might improve diagnostic accuracy and extend the examination of specific
      area of interest in the gastrointestinal tract.
    

Intervention name(s): capsule endoscopy
Intervention type(s): Device
Intervention description(s): The magnetic navigated CE would enable detailed investigations of the whole upper gastrointestinal tract, including the esophagus, stomach and duodenum. Using this remote magnetic manipulation, capsule endoscope might improve diagnostic accuracy and extend the examination of specific area of interest in the gastrointestinal tract.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic