肥胖症内镜设备的监管视角

The Regulatory Perspectives on Endoscopic Devices for Obesity.

作者信息

Marrone April K, Antonino Mark J, Silverstein Joshua S, Betz Martha W, Venkataraman-Rao Priya, Golding Martin, Cordray Diane, Cooper Jeffrey W

机构信息

Gastroenterology Devices Branch of the Division of Reproductive Gastro-Renal and Urological Devices, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Building 66, Room G218, Silver Spring, MD 20993-0002, USA.

出版信息

Gastrointest Endosc Clin N Am. 2017 Apr;27(2):327-341. doi: 10.1016/j.giec.2016.12.004.

DOI:10.1016/j.giec.2016.12.004

PMID:28292410

Abstract

The recent increase in US Food and Drug Administration-approved weight-loss devices has diversified obesity treatment options. The regulatory pathways for endoscopically placed weight-loss devices and considerations for clinical trials are discussed, including the benefit-risk paradigm intended to aid in weight-loss-device trial development. Also discussed is the benefit-risk analysis of recently approved endoscopic devices. A strategic priority of the FDA Center for Devices and Radiological Health is to increase the use of patient input in decision making. Thus, we consider how endoscopic weight-loss devices with profiles similar to those that have been approved may be viewed in a patient preference study.

摘要

美国食品药品监督管理局（FDA）近期批准的减肥设备有所增加，这使肥胖治疗选择更加多样化。本文讨论了内镜下放置减肥设备的监管途径以及临床试验的注意事项，包括有助于减肥设备试验开发的获益-风险模式。还讨论了近期获批的内镜设备的获益-风险分析。FDA器械与放射健康中心的一项战略重点是在决策过程中增加患者意见的纳入。因此，我们思考了在一项患者偏好研究中，具有与已获批设备相似特征的内镜减肥设备会如何被看待。