A multicenter, prospective, randomized comparison of a novel signal transmission capsule endoscope to an existing capsule endoscope

Eric H. Choi, Klaus Mergener, Carol Semrad, Laurel Fisher, David R. Cave, Milan Dodig, Carol Burke, Jonathan A. Leighton, David Kastenberg, Peter Simpson, James Sul, Kanishka Bhattacharya, Roger Charles, Lauren Gerson, Luke Weber, Glenn Eisen, Warren Reidel, John J. Vargo, Jamile Wakim-Fleming, Simon K. Lo

Research output: Contribution to journalArticlepeer-review

17 Scopus citations

Abstract

Background: MiroCam, a capsule endoscope, uses a novel transmission technology, electric-field propagation, which uses the human body as a conduction medium for data transmission. Objective: To compare the ability of the MiroCam (MC) and PillCam (PC) to identify sources of obscure GI bleeding (OGIB). Design: Prospective, multicenter, comparative study. Setting: Six academic hospitals. Patients: A total of 105 patients with OGIB. Intervention: Patients ingested both the MC and PC capsules sequentially in a randomized fashion. Main Outcome Measurements: Concordance of rates in identifying a source of OGIB, operational times, and rates of complete small-bowel examination. Results: Data analysis resulted in 43 (48%) "abnormal" cases identifying a source of OGIB by either capsule. Twenty-four cases (55.8%) were positive by both capsules. There was negative agreement in 46 of 58 cases (79.3%). The κ index was 0.547 (χ2 = 1.32; P =.36). In 12 cases, MC positively identified a source that was not seen on PC, whereas in 7 cases, PC positively identified a source that was not seen on MC. MC had a 5.6% higher rate of detecting small-bowel lesions (P =.54). MC captured images at 3 frames per second for 11.1 hours, and PC captured images at 2 frames per second for 7.8 hours (P <.0001). Complete small-bowel examination was achieved in 93.3% for MC and 84.3% for PC (P =.10). Limitations: Readers were not blinded to the particular capsule they were reading. Conclusion: A positive diagnostic finding for OGIB was identified by either capsule in 48% of cases. The concordance rate between the 2 capsules was comparable to that of prior studies in identifying sources of small-bowel bleeding. The longer operational time of the MC may result in higher rates of complete small-bowel examination, which may, in turn, translate into a higher rate of detecting small-bowel lesions. (Clinical trial registration number: NCT00878982.).

Original languageEnglish (US)
Pages (from-to)325-332
Number of pages8
JournalGastrointestinal endoscopy
Volume78
Issue number2
DOIs
StatePublished - Aug 2013

Keywords

  • CE
  • MC
  • MiroCam
  • OGIB
  • PC
  • PillCam
  • capsule endoscopy
  • obscure GI bleeding

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

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