用于OTSC和FTRD夹子移除的remOVE系统的有效性和安全性：来自上市后临床随访分析的数据
Efficacy and safety of the remOVE System for OTSC and FTRD clip removal: data from a PMCF analysis.
作者信息
Caputo Antonio, Schmidt Arthur, Caca Karel, Bauerfeind Peter, Schostek Sebastian, Ho Chi-Nghia, Gottwald Thomas, Schurr Marc O
机构信息
a Ovesco Endoscopy AG , Tuebingen , Germany.
b Department of Gastroenterology and Oncology , Klinikum Ludwigsburg , Ludwigsburg , Germany.
出版信息
Minim Invasive Ther Allied Technol. 2018 Jun;27(3):138-142. doi: 10.1080/13645706.2017.1335643. Epub 2017 Jun 13.
INTRODUCTION
The remOVE System (Ovesco Endoscopy AG, Tuebingen, Germany) is a medical device for the endoscopic removal of OTSC or FTRD clips (Ovesco Endoscopy AG, Tuebingen, Germany). The aim of this paper is to assess the efficacy and safety of this system.
MATERIAL AND METHODS
A total of 74 patients underwent clip extraction. The standard removal procedure comprises fragmenting the clip by applying an electrical direct current pulse at two opposing sides of the clip.
RESULTS
Clip fragmentation was successful in 72 of 74 patients (97.3%). In two cases (2.7%) clip fragmentation was not possible. In nine cases (12.2%) a clip fragment could not be removed and was left in place. Complications occurred in three cases (4.1%): two minor bleedings near the clip removal site (2.7%), and one superficial mucosal tear resulting from clip fragment extraction (1.4%).
DISCUSSION
Based on this study, the use of the remOVE System for OTSC or FTRD clip removal can be considered safe and effective.
引言
remOVE系统（德国图宾根的Ovesco Endoscopy AG公司）是一种用于在内镜下移除OTSC或FTRD夹子（德国图宾根的Ovesco Endoscopy AG公司）的医疗器械。本文旨在评估该系统的有效性和安全性。
材料与方法
共有74例患者接受了夹子取出术。标准的取出程序包括通过在夹子的两个相对侧施加直流脉冲来使夹子破碎。
结果
74例患者中有72例（97.3%）夹子破碎成功。2例（2.7%）无法实现夹子破碎。9例（12.2%）夹子碎片无法取出而留在原位。3例（4.1%）出现并发症：2例在夹子取出部位附近出现轻微出血（2.7%），1例因夹子碎片取出导致浅表黏膜撕裂（1.4%）。
讨论
基于本研究，使用remOVE系统移除OTSC或FTRD夹子可被认为是安全有效的。
Zotero 插件