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

doi:10.1016/j.gie.2013.02.039

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

Gastroenterology and Hepatology

Research output: Contribution to journal › Article › peer-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 language	English (US)
Pages (from-to)	325-332
Number of pages	8
Journal	Gastrointestinal endoscopy
Volume	78
Issue number	2
DOIs	https://doi.org/10.1016/j.gie.2013.02.039
State	Published - 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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10.1016/j.gie.2013.02.039

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Choi, E. H., Mergener, K., Semrad, C., Fisher, L., Cave, D. R., Dodig, M., Burke, C., Leighton, J. A., Kastenberg, D., Simpson, P., Sul, J., Bhattacharya, K., Charles, R., Gerson, L., Weber, L., Eisen, G., Reidel, W., Vargo, J. J., Wakim-Fleming, J., & Lo, S. K. (2013). A multicenter, prospective, randomized comparison of a novel signal transmission capsule endoscope to an existing capsule endoscope. Gastrointestinal endoscopy, 78(2), 325-332. https://doi.org/10.1016/j.gie.2013.02.039

Choi, EH, Mergener, K, Semrad, C, Fisher, L, Cave, DR, Dodig, M, Burke, C, Leighton, JA, Kastenberg, D, Simpson, P, Sul, J, Bhattacharya, K, Charles, R, Gerson, L, Weber, L, Eisen, G, Reidel, W, Vargo, JJ, Wakim-Fleming, J & Lo, SK 2013, 'A multicenter, prospective, randomized comparison of a novel signal transmission capsule endoscope to an existing capsule endoscope', Gastrointestinal endoscopy, vol. 78, no. 2, pp. 325-332. https://doi.org/10.1016/j.gie.2013.02.039

@article{547a31a949fe45049598fa36604ce565,

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

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.).",

keywords = "CE, MC, MiroCam, OGIB, PC, PillCam, capsule endoscopy, obscure GI bleeding",

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

year = "2013",

month = aug,

doi = "10.1016/j.gie.2013.02.039",

language = "English (US)",

volume = "78",

pages = "325--332",

journal = "Gastrointestinal endoscopy",

issn = "0016-5107",

publisher = "Elsevier Inc.",

number = "2",

}

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T1 - A multicenter, prospective, randomized comparison of a novel signal transmission capsule endoscope to an existing capsule endoscope

AU - Choi, Eric H.

AU - Mergener, Klaus

AU - Semrad, Carol

AU - Fisher, Laurel

AU - Cave, David R.

AU - Dodig, Milan

AU - Burke, Carol

AU - Leighton, Jonathan A.

AU - Kastenberg, David

AU - Simpson, Peter

AU - Sul, James

AU - Bhattacharya, Kanishka

AU - Charles, Roger

AU - Gerson, Lauren

AU - Weber, Luke

AU - Eisen, Glenn

AU - Reidel, Warren

AU - Vargo, John J.

AU - Wakim-Fleming, Jamile

AU - Lo, Simon K.

PY - 2013/8

Y1 - 2013/8

N2 - 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.).

AB - 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.).

KW - CE

KW - MC

KW - MiroCam

KW - OGIB

KW - PC

KW - PillCam

KW - capsule endoscopy

KW - obscure GI bleeding

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

Abstract

Keywords

ASJC Scopus subject areas

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