A comparison of 2 distal attachment mucosal exposure devices: a noninferiority randomized controlled trial

Douglas Rex, Sashidhar V. Sagi, William Kessler, Nicholas Rogers, Monika Fischer, Matthew Bohm, John DeWitt, Rachel E. Lahr, Meghan P. Searight, Andrew W. Sullivan, Connor D. McWhinney, Jonathan R. Garcia, Heather M. Broadley, Krishna C. Vemulapalli

Research output: Contribution to journalArticle

Abstract

Background and Aims: Endocuff (Arc Medical Design, Leeds, UK) and Endocuff Vision (Arc Medical Design, Leeds, UK) are effective mucosal exposure devices for improving polyp detection during colonoscopy. AmplifEYE (Medivators Inc, Minneapolis, Minn, USA) is a device that appears similar to the Endocuff devices but has received minimal clinical testing. Methods: We performed a randomized controlled clinical trial using a noninferiority design to compare Endocuff Vision with AmplifEYE. Results: The primary endpoint of adenomas per colonoscopy was similar in AmplifEYE at 1.63 (standard deviation 2.83) versus 1.51 (2.29) with Endocuff Vision (P = .535). The 95% lower confidence limit was 0.88 for ratio of means, establishing noninferiority of AmplifEYE (P = .008). There was no difference between the arms for mean insertion time, and mean inspection time (withdrawal time minus polypectomy time and time for washing and suctioning) was shorter with AmplifEYE (6.8 minutes vs 6.9 minutes, P = .042). Conclusions: AmplifEYE is noninferior to Endocuff Vision for adenoma detection. The decision on which device to use can be based on cost. Additional comparisons of AmplifEYE with Endocuff by other investigators are warranted. (Clinical trial registration number: NCT03560128.)

Original languageEnglish (US)
JournalGastrointestinal endoscopy
DOIs
StateAccepted/In press - Jan 1 2019

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Randomized Controlled Trials
Equipment and Supplies
Colonoscopy
Adenoma
Polyps
Research Personnel
Clinical Trials
Costs and Cost Analysis

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

Cite this

A comparison of 2 distal attachment mucosal exposure devices : a noninferiority randomized controlled trial. / Rex, Douglas; Sagi, Sashidhar V.; Kessler, William; Rogers, Nicholas; Fischer, Monika; Bohm, Matthew; DeWitt, John; Lahr, Rachel E.; Searight, Meghan P.; Sullivan, Andrew W.; McWhinney, Connor D.; Garcia, Jonathan R.; Broadley, Heather M.; Vemulapalli, Krishna C.

In: Gastrointestinal endoscopy, 01.01.2019.

Research output: Contribution to journalArticle

Rex, Douglas ; Sagi, Sashidhar V. ; Kessler, William ; Rogers, Nicholas ; Fischer, Monika ; Bohm, Matthew ; DeWitt, John ; Lahr, Rachel E. ; Searight, Meghan P. ; Sullivan, Andrew W. ; McWhinney, Connor D. ; Garcia, Jonathan R. ; Broadley, Heather M. ; Vemulapalli, Krishna C. / A comparison of 2 distal attachment mucosal exposure devices : a noninferiority randomized controlled trial. In: Gastrointestinal endoscopy. 2019.
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AU - Rogers, Nicholas

AU - Fischer, Monika

AU - Bohm, Matthew

AU - DeWitt, John

AU - Lahr, Rachel E.

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AU - Vemulapalli, Krishna C.

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