Indiana University School of Medicine, Indianapolis, Indiana, USA.
Gastrointest Endosc. 2019 Nov;90(5):835-840.e1. doi: 10.1016/j.gie.2019.06.046. Epub 2019 Jul 15.
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.
We performed a randomized controlled clinical trial using a noninferiority design to compare Endocuff Vision with AmplifEYE.
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).
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.).
Endocuff（Arc Medical Design，英国利兹）和 Endocuff Vision（Arc Medical Design，英国利兹）是两种有效的黏膜暴露装置，可提高结肠镜检查中息肉的检测率。AmplifEYE（Medivators Inc，美国明尼苏达州明尼阿波利斯）是一种外观类似于 Endocuff 装置的设备，但临床测试较少。
我们采用非劣效性设计进行了一项随机对照临床试验，以比较 Endocuff Vision 与 AmplifEYE。
腺瘤检出率是 AmplifEYE 的主要终点，为 1.63（标准差 2.83），Endocuff Vision 为 1.51（标准差 2.29）（P=0.535）。比值均数的 95%置信下限为 0.88，证实了 AmplifEYE 的非劣效性（P=0.008）。两组的平均插入时间无差异，而 AmplifEYE 的平均检查时间（退出时间减去息肉切除术时间和清洗及抽吸时间）更短（6.8 分钟对 6.9 分钟，P=0.042）。
AmplifEYE 在腺瘤检测方面与 Endocuff Vision 相当。可以根据成本来决定使用哪种设备。其他研究者对 AmplifEYE 与 Endocuff 的进一步比较是合理的。（临床试验注册号：NCT03560128.）。
