Maneuverability and safety of a magnetic-controlled capsule endoscopy system to examine the human colon under real-time monitoring by colonoscopy: a pilot study (with video)

Abstract

Background and aims: Colon capsule endoscopy has become an alternative method to evaluate the colonic mucosa without pain, sedation, and gas insufflation in recent years. The magnetic-controlled capsule endoscopy (MCCE) system is an innovative ingestible colon capsule. We performed a pilot study to assess its maneuverability and safety among subjects who volunteered to undergo colorectal cancer screening.

Methods: Fifty-seven volunteers underwent both MCCE and colonoscopy procedures. The position of the MCCE was monitored after the capsule was swallowed. When the MCCE reached the cecum, it was controlled by a magnetic manipulator to observe the colonic mucosa under real-time monitoring by colonoscopy. The primary measurements included maneuverability, the level of cleanliness, lesions, and safety.

Results: Five volunteers (8.78%) were excluded because of bowel preparation protocol deviations or failure to reach the cecum before the battery was exhausted. There was no capsule retention. Maneuverability of the MCCE to match the guidance of the magnetic manipulator was graded as good in 49 subjects (94.23%) and moderate in 3 (5.77%). It took 3.63 ± 1.14 hours for the MCCE to reach the cecum. In 52 subjects (100%) the MCCE reached the transverse colon positively, and in 41 subjects (78.84%) the MCCE reached the rectosigmoid colon within a limited time of 25 minutes. The bowel preparation for MCCE was rated as good or excellent in 84.61% of the volunteers. Six positive findings were identified by the MCCE in the colon, which were also confirmed by colonoscopy.

Conclusions: The MCCE showed promising maneuverability under real-time monitoring by colonoscopy. (Clinical trial registration number: NCT02536144.).