Abstract
Background and study aim
Current capsule endoscopy procedures are ineffective for upper gastrointestinal (GI) tract examination because they do not allow for operator-controlled navigation of the capsule. External controllability of a capsule endoscope with an applied magnetic field is a possible solution to this problem. We developed a novel magnetic-assisted capsule endoscope (MACE) system to visualize the entire upper GI tract. The present study evaluated the safety and feasibility of the MACE system for the examination of the upper GI tract, including the esophagus, stomach, and duodenum.
Methods
The present open clinical study enrolled ten healthy volunteers. All participants swallowed a MACE, and an external magnetic field navigator was used for magnetic capsule manipulation in the upper GI tract. We assessed the maneuverability of the magnetic capsule and completeness of the MACE examination as well as the safety and tolerability of the procedure.
Results
The present study enrolled ten healthy volunteers with a mean age and body mass index of 47.7 years and 25.6 kg/m2, respectively. One volunteer withdrew because of difficulty in swallowing the capsule. In total, nine volunteers underwent the MACE examination. The average examination time was 27.1 min. The maneuverability of the capsule was assessed as good and fair in 55.6 and 44.4% of the participants, respectively. The overall completeness of the examination in the esophagus, stomach, and duodenum was 100, 85.2, and 86.1%, respectively. No severe adverse events occurred during this study. All participants exhibited satisfactory tolerance of the MACE examination.
Conclusion
The MACE system has satisfactory maneuverability and visualization completeness with excellent acceptance and tolerance.
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Abbreviations
- BMI:
-
Body mass index
- CMOS:
-
Complementary metal-oxide semiconductor
- Fps:
-
Frame per second
- GI:
-
Gastrointestinal
- LED:
-
Light-emitting diodes
- MACE:
-
Magnetic-assisted capsule endoscope
- MFN:
-
Magnetic field navigator
- VAS:
-
Visual analog scale
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Contributions
CW Liu, FM Suk, and GS Lien contributed to conception and design. MS Wu and CN Chan were involved in data collection; all authors involved in interpretation of data and editing the manuscript. All authors revised the manuscript together and approved the final version of this manuscript.
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Disclosures
Gi-Shih Lien, Ming-Shun Wu, Chun-Nan Chen, Chih-Wen Liu, and Fat-Moon Suk have no potential conflicts of interest or financial ties to disclose.
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464_2017_5887_MOESM1_ESM.wmv
Video clip 1 Use of the hand-held magnetic field navigator to move the capsule from the cardia to the antrum and pass through the pylorus. (WMV 6435 KB)
464_2017_5887_MOESM2_ESM.wmv
Video clip 2 Reversal of the capsule endoscope through magnetic manipulation in the duodenal bulb. The cable serves as a landmark of the pylorus for capsule retroversion. (WMV 9638 KB)
464_2017_5887_MOESM3_ESM.wmv
Video clip 3 Reversal of the hand-held magnetic field navigator and movement of the capsule proximally to the angulus, body, and cardia of the stomach. (WMV 13208 KB)
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Lien, GS., Wu, MS., Chen, CN. et al. Feasibility and safety of a novel magnetic-assisted capsule endoscope system in a preliminary examination for upper gastrointestinal tract. Surg Endosc 32, 1937–1944 (2018). https://doi.org/10.1007/s00464-017-5887-0
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DOI: https://doi.org/10.1007/s00464-017-5887-0