椎体成形球囊扩张导管临床试验设计思考  

Considerations on the Clinical Trial Design of Inflatable Bone Expander

作　　者：阿茹罕 张家振 翟豹 李铮 刘斌 郭亚娟 A Ru-han;ZHANG Jia-zhen;ZHAI Bao;LI Zheng;LIU Bin;GUO Ya-juan(Center for Medical Device Evaluation,National Medical Product Administration,Beijing 100081)

机构地区：[1]国家药品监督管理局医疗器械技术审评中心,北京100081

出　　处：《中国医疗器械信息》2021年第21期3-6,19,共5页China Medical Device Information

摘　　要：目的:探讨如何通过临床试验途径提供充分合理的临床试验证据评价椎体成形球囊扩张导管的安全性和有效性。方法:通过搜集查阅相关领域临床文献,国家行业标准、指导原则以及已上市产品临床表现等,探索合理的临床试验方案及评价体系。结果:对于椎体成形球囊扩张导管的临床试验而言,易产生分歧的内容可能包括试验目的、临床试验设计类型、纳入与排出标准、临床试验评价指标和判定标准以及临床试验观察时间等方面,从而增加了临床试验设计难度。结论:临床试验申办者应结合产品设计开发过程中的风险评估结果,明确临床试验目的,从而制定出科学有效的临床试验方案,以确保产品的安全性和有效性。Objective:This article was discussing the clinical trials that can provide sufficient and reasonable clinical trial evidence to evaluate the safety and effectiveness of the Inflatable Bone Expander.Methods:By collecting and consulting clinical literature,national industry standards,guidelines in related fields,and clinical performance of marketed products,reasonable clinical trial plans and evaluation systems has been explored.Results:For the clinical trials of these devices,the purpose,design type,entry and discharge standards,evaluation indicators and judgment standards,observation time of the clinical trial were prone to divergence,which increased the difficulties of designing the clinical trial.Conclusion:The investigator should combine the risk assessment results during design and development process of the product,and clarify the purpose of the clinical trial.The aim is to formulate a scientific and effective clinical trial plan to ensure the safety and effectiveness of the product.

关 键 词：椎体后凸成形术 椎体成型球囊扩张导管 骨质疏松性椎体压缩骨折 临床试验评价指标 临床试验 临床评价 

分 类 号：TH781[机械工程—仪器科学与技术]