使用OMOM CC100系统进行远程结肠囊内镜的前性,多中心可行性研究
Alexandra Agache1,2,3, Ervin Toth4,5, Niels Qvist2
1Department of Clinical Research, University of Southern Denmark (SDU), 5000 Odense C, Denmark.
使用OMOM CC100系统的结肠囊内镜 (CCE) 是安全的和可行的,证明了各种胃肠道疾病的良好诊断产量. 远程管理提高了患者的满意度和可访问性,支持分散的护理模式.
科学领域:
- 胃肠病学 胃肠病学
- 医疗器械 医疗器械
- 内镜检查是指内镜检查.
背景情况:
- 结肠囊内镜 (CCE) 为传统结肠镜提供了一个非侵入性的替代方案.
- 分散的护理模式正在出现,以改善胃肠道诊断的可访问性.
研究的目的:
- 评估OMOM CC100 CCE系统的可行性,安全性,诊断产量和患者满意度.
- 评估完全和部分远程管理的有效性,以推进分散的CCE模型.
主要方法:
- 一项前性,国际多中心可行性研究,涉及119名患者 (年龄18-75岁).
- 使用了OMOM CC100囊与标准化肠道制备.
- 在四个欧洲中心比较完全远程 (IntelliGITM平台) 和部分远程管理.
主要成果:
- 总体完成率为79%, 71%的患者有足够的肠道清洁.
- 诊断产量包括多 (25),血管切除 (20),粘膜炎 (17);42%的检查正常.
- 完全远程管理实现了80%的完成率和89.7%的满意度;整体患者满意度为81%.
结论:
- OMOM CC100 CCE 系统是可行的,安全的,并提供与现有系统相比的诊断产量.
- 支持IntelliGITM的远程管理促进了去中心化的CCE,改善了可访问性和患者对家庭程序的偏好.
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