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中华疝和腹壁外科杂志(电子版) ›› 2020, Vol. 14 ›› Issue (04) : 327 -330. doi: 10.3877/cma.j.issn.1674-392X.2020.04.002

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疝修补补片类医疗器械的临床试验设计考量
刘文博1,(), 史新立1, 赵鹏1, 邢丽娜1, 张书培1, 汤菊莉1, 黄长瑾1   
  1. 1. 100081 北京,国家药品监督管理局医疗器械技术审评中心
  • 收稿日期:2020-01-11 出版日期:2020-08-18
  • 通信作者: 刘文博

Design of clinical investigations for hernia meshes

Wenbo Liu1,(), Xinli Shi1, Peng Zhao1, Lina Xing1, Shupei Zhang1, Juli Tang1, Changjin Huang1   

  1. 1. Center for Medical Device Evaluation, National Medical Products Administration, Beijing 100081, China
  • Received:2020-01-11 Published:2020-08-18
  • Corresponding author: Wenbo Liu
  • About author:
    Corresponding author: Liu Wenbo, Email:
引用本文:

刘文博, 史新立, 赵鹏, 邢丽娜, 张书培, 汤菊莉, 黄长瑾. 疝修补补片类医疗器械的临床试验设计考量[J]. 中华疝和腹壁外科杂志(电子版), 2020, 14(04): 327-330.

Wenbo Liu, Xinli Shi, Peng Zhao, Lina Xing, Shupei Zhang, Juli Tang, Changjin Huang. Design of clinical investigations for hernia meshes[J]. Chinese Journal of Hernia and Abdominal Wall Surgery(Electronic Edition), 2020, 14(04): 327-330.

疝修补补片作为一种持久植入人体内的医疗器械,其安全性及有效性对患者的生存质量至关重要,而临床试验是疝补片上市前安全性及有效性评价的重要方式之一。在对多项疝补片产品上市前临床试验资料技术审评及有关文献汇总分析的基础上,本文对该类器械临床试验设计的各个要素进行了探讨并给出相关建议,供疝补片类医疗器械的制造企业、普外科临床医师在开展此类产品临床试验时予以参考。

Hernia meshes are permanent implants. As a result, the safety and effectiveness of hernia meshes are crucial to patients' quality of life. Conducting clinical investigations or trials are one of the important methods to evaluate the safety and effectiveness of hernia meshes. Based on the technical evaluation of clinical data of multiple hernia mesh products as well as analysis of relevant literatures, this article discusses key principles and factors regarding the design of clinical investigations for hernia meshes. Specific recommendations are also provided to sponsors and clinical investigators for hernia meshes clinical studies.

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