Vol.:(0123456789) 1 3 Surg Endosc (2018) 32:1937–1944 DOI 10.1007/s00464-017-5887-0 Feasibility and safety of a novel magnetic-assisted capsule endoscope system in a preliminary examination for upper gastrointestinal tract Gi-Shih Lien 1,2  · Ming-Shun Wu 1,2  · Chun-Nan Chen 1  · Chih-Wen Liu 3  · Fat-Moon Suk 1,2   Received: 30 May 2017 / Accepted: 13 September 2017 / Published online: 25 October 2017 © Springer Science+Business Media, LLC 2017 of the MACE examination as well as the safety and toler- ability 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/m 2 , respectively. One volunteer withdrew because of difculty in swallowing the capsule. In total, nine vol- unteers 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 maneuver- ability and visualization completeness with excellent accept- ance and tolerance. Keywords Capsule endoscope · Esophagus · Stomach · Duodenum 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 feld navigator VAS Visual analog scale Capsule endoscopy has been widely adopted for the nonin- vasive endoscopic examination of the digestive tract since its introduction in 2001 [1]. Several capsule endoscopy systems Abstract Background and study aim Current capsule endoscopy procedures are inefective 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 feld 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 evalu- ated 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 feld navigator was used for magnetic capsule manipulation in the upper GI tract. We assessed the maneuverability of the magnetic capsule and completeness and Other Interventional Techniques Gi-Shih Lien and Ming-Shun Wu have contributed equally to this work. Electronic supplementary material The online version of this article (doi:10.1007/s00464-017-5887-0) contains supplementary material, which is available to authorized users. * Fat-Moon Suk fmsuk@tmu.edu.tw 1 Division of Gastroenterology, Department of Internal Medicine, Taipei Municipal Wan Fang Hospital, Taipei Medical University, No. 111, Section 3, Xing Long Road, Taipei 116, Taiwan 2 Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan 3 Department of Electrical Engineering, National Taiwan University, Taipei, Taiwan