title: Evaluation of performance of the Omni mode for detecting video capsule endoscopy images: A multicenter randomized controlled trial.
abstract: OBJECTIVE
  Olympus recently developed a new algorithm called Omni mode that discards redundant video capsule endoscopy (VCE) images. The current study aimed to demonstrate the non-inferiority of the Omni mode in terms of true positives (TPs) and the superiority of the Omni mode with regard to reading time against a control (ordinary ES-10 system).
  
  
  METHODS
  This multicenter prospective study included 40 patients with various small bowel diseases. VCE images were evaluated by 7 readers and 3 judging committee members. Two randomly allocated readers assessed the VCE images obtained using the 2 modalities for each patient. The order of the modalities was switched between the 2 readers and the interval between readings by the same reader was 2 weeks. The judging committee predefined clinically relevant lesions as major lesions and irrelevant lesions as minor lesions. The number of TPs for major and minor lesions and the reading times were compared between the modalities. The predefined non-inferiority margin for the TP ratio of the Omni mode compared with the control was 0.9.
  
  
  RESULTS
  The estimated TP ratios and 95 % confidence intervals for total, major, and minor lesions were 0.87 (0.80 - 0.95), 0.93 (0.83 - 1.04), and 0.83 (0.74 - 0.94), respectively. Although non-inferiority was not demonstrated, the rate of detection of major lesions was not significantly different between the modalities. The reading time was significantly lower when using the Omni mode than when using the control.
  
  
  CONCLUSIONS
  The Omni mode may be only appropriate for the assessment of major lesions.
authors.affiliation: Center for Diagnostic and Therapeutic Endoscopy, School of Medicine, Keio University, Tokyo, Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Hosoe
authors.affiliation: Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Watanabe
authors.affiliation: Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan.
authors.forename: Takako
authors.initials: T
authors.lastname: Miyazaki
authors.affiliation: Third Department of Internal Medicine, Kansai Medical University, Osaka, Japan.
authors.forename: Masaaki
authors.initials: M
authors.lastname: Shimatani
authors.affiliation: Third Department of Internal Medicine, Kansai Medical University, Osaka, Japan.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Wakamatsu
authors.affiliation: Third Department of Internal Medicine, Kansai Medical University, Osaka, Japan.
authors.forename: Kazuichi
authors.initials: K
authors.lastname: Okazaki
authors.affiliation: Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Motohiro
authors.initials: M
authors.lastname: Esaki
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, School of Medicine, Iwate Medical University, Morioka, Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Matsumoto
authors.affiliation: Department of Preventive Medicine and Public Health, Biostatistics at Center for Clinical Research, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Abe
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Takanori
authors.initials: T
authors.lastname: Kanai
authors.affiliation: Department of Gastroenterology, School of Medicine, Tokyo Medical and Dental University, Tokyo, Japan.
authors.forename: Kazuo
authors.initials: K
authors.lastname: Ohtsuka
authors.affiliation: Department of Gastroenterology, School of Medicine, Tokyo Medical and Dental University, Tokyo, Japan.
authors.forename: Mamoru
authors.initials: M
authors.lastname: Watanabe
authors.affiliation: Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Keiichi
authors.initials: K
authors.lastname: Ikeda
authors.affiliation: Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Hisao
authors.initials: H
authors.lastname: Tajiri
authors.affiliation: Department of Gastroenterology, School of Medicine, Fujita Health University, Aichi, Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Ohmiya
authors.affiliation: Department of Gastroenterology, Nagoya Graduate School of Medicine, Nagoya, Japan.
authors.forename: Masanao
authors.initials: M
authors.lastname: Nakamura
authors.affiliation: Department of Gastroenterology, Nagoya Graduate School of Medicine, Nagoya, Japan.
authors.forename: Hidemi
authors.initials: H
authors.lastname: Goto
authors.affiliation: Comprehensive Internal Medicine, Shiga University of Medical Science, Shiga, Japan.
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Tsujikawa
authors.affiliation: Center for Diagnostic and Therapeutic Endoscopy, School of Medicine, Keio University, Tokyo, Japan.
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Ogata