Skip to main content
Log in

Feasibility and safety of a novel magnetic-assisted capsule endoscope system in a preliminary examination for upper gastrointestinal tract

  • Published:
Surgical Endoscopy Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1
Fig. 2

Similar content being viewed by others

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

References

  1. Iddan G, Meron G, Glukhovsky A, Swain P (2000) Wireless capsule endoscopy. Nature 405:417

    Article  CAS  PubMed  Google Scholar 

  2. Carpi F, Galbiati S, Carpi A (2006) Magnetic shells for gastrointestinal endoscopic capsules as a means to control their motion. Biomed Pharmacother 60:370–374

    Article  CAS  PubMed  Google Scholar 

  3. Rahman I, Pioche M, Shim CS, Lee SP, Sung IK, Saurin JC, Patel P (2016) Magnetic-assisted capsule endoscopy in the upper GI tract by using a novel navigation system (with video). Gastrointest Endosc 83:889–895 e881

    Article  PubMed  Google Scholar 

  4. Keller J, Fibbe C, Volke F, Gerber J, Mosse AC, Reimann-Zawadzki M, Rabinovitz E, Layer P, Swain P (2010) Remote magnetic control of a wireless capsule endoscope in the esophagus is safe and feasible: results of a randomized, clinical trial in healthy volunteers. Gastrointest Endosc 72:941–946

    Article  PubMed  Google Scholar 

  5. Keller J, Fibbe C, Rosien U, Layer P (2012) Recent advances in capsule endoscopy: development of maneuverable capsules. Expert Rev Gastroenterol Hepatol 6:561–566

    Article  CAS  PubMed  Google Scholar 

  6. Keller J, Fibbe C, Volke F, Gerber J, Mosse AC, Reimann-Zawadzki M, Rabinovitz E, Layer P, Schmitt D, Andresen V, Rosien U, Swain P (2011) Inspection of the human stomach using remote-controlled capsule endoscopy: a feasibility study in healthy volunteers (with videos). Gastrointest Endosc 73:22–28

    Article  PubMed  Google Scholar 

  7. Swain P, Toor A, Volke F, Keller J, Gerber J, Rabinovitz E, Rothstein RI (2010) Remote magnetic manipulation of a wireless capsule endoscope in the esophagus and stomach of humans (with videos). Gastrointest Endosc 71:1290–1293

    Article  PubMed  Google Scholar 

  8. Rey JF, Ogata H, Hosoe N, Ohtsuka K, Ogata N, Ikeda K, Aihara H, Pangtay I, Hibi T, Kudo SE, Tajiri H (2012) Blinded nonrandomized comparative study of gastric examination with a magnetically guided capsule endoscope and standard video endoscope. Gastrointest Endosc 75:373–381

    Article  PubMed  Google Scholar 

  9. Rey JF, Ogata H, Hosoe N, Ohtsuka K, Ogata N, Ikeda K, Aihara H, Pangtay I, Hibi T, Kudo S, Tajiri H (2010) Feasibility of stomach exploration with a guided capsule endoscope. Endoscopy 42:541–545

    Article  CAS  PubMed  Google Scholar 

  10. Denzer UW, Rosch T, Hoytat B, Abdel-Hamid M, Hebuterne X, Vanbiervielt G, Filippi J, Ogata H, Hosoe N, Ohtsuka K, Ogata N, Ikeda K, Aihara H, Kudo SE, Tajiri H, Treszl A, Wegscheider K, Greff M, Rey JF (2015) Magnetically guided capsule versus conventional gastroscopy for upper abdominal complaints: a prospective blinded study. J Clin Gastroenterol 49:101–107

    Article  PubMed  Google Scholar 

  11. Liao Z, Duan XD, Xin L, Bo LM, Wang XH, Xiao GH, Hu LH, Zhuang SL, Li ZS (2012) Feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human stomach: a pilot study in healthy volunteers. J Interv Gastroenterol 2:155–160

    Article  PubMed  PubMed Central  Google Scholar 

  12. Zou WB, Hou XH, Xin L, Liu J, Bo LM, Yu GY, Liao Z, Li ZS (2015) Magnetic-controlled capsule endoscopy vs. gastroscopy for gastric diseases: a two-center self-controlled comparative trial. Endoscopy 47:525–528

    Article  PubMed  Google Scholar 

  13. Lien GS, Liu CW, Jiang JA, Chuang CL, Teng MT (2012) Magnetic control system targeted for capsule endoscopic operations in the stomach–design, fabrication, and in vitro and ex vivo evaluations. IEEE Trans Biomed Eng 59:2068–2079

    Article  PubMed  Google Scholar 

  14. Chang CC, Chen SH, Lin CP, Hsieh CR, Lou HY, Suk FM, Pan S, Wu MS, Chen JN, Chen YF (2007) Premedication with pronase or N-acetylcysteine improves visibility during gastroendoscopy: an endoscopist-blinded, prospective, randomized study. World J Gastroenterol 13:444–447

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  15. Liu S, Li J, Lv Y (2012) Gastrointestinal damage caused by swallowing multiple magnets. Front Med 6:280–287

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

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.

Corresponding author

Correspondence to Fat-Moon Suk.

Ethics declarations

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.

Electronic supplementary material

Below is the link to the electronic supplementary material.

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)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

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

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00464-017-5887-0

Keywords

Navigation