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

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.).

journal_name

Gastrointest Endosc

journal_title

Gastrointestinal endoscopy

authors

Rex DK,Sagi SV,Kessler WR,Rogers NA,Fischer M,Bohm ME,Dewitt JM,Lahr RE,Searight MP,Sullivan AW,McWhinney CD,Garcia JR,Broadley HM,Vemulapalli KC

doi

10.1016/j.gie.2019.06.046

subject

Has Abstract

pub_date

2019-11-01 00:00:00

pages

835-840.e1

issue

5

eissn

0016-5107

issn

1097-6779

pii

S0016-5107(19)32057-7

journal_volume

90

pub_type

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