激光类医疗器械临床试验方案设计探讨

Discussion on Design of Clinical Trial Protocol of Laser Medical Devices

摘要: 该研究介绍了国内激光类医疗器械分类情况，探讨了激光类医疗器械临床试验方案设计要点，如对照选择、评价指标、评价方式、入排标准的确定、盲法的应用，强调了试验过程中的医疗器械缺陷管理的重要性，为方案涉及人员提供参考。

Abstract: Guidance and reference are provided for protocol designer. The classification of laser medical devices are introduced. The key points such as the selection of control group, evaluation indicators and method, criteria of inclusion and exclusion, and application of blinded, etc. are discussed, and the importance of management of defects in medical device is emphasized.