腹/盆腔手术用可吸收防粘连产品临床研究中常见问题的思考

      The Refl ection on Common Problems of Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery Clinical Studies

      • 摘要: 腹/盆腔手术用可吸收防粘连产品是植入性高风险医疗器械,临床研究存在一定困难,本文从技术审评的角度,对其临床研究的常见问题进行了归纳和分析,以期为我国相关申报企业和临床研究人员在设计和开展该类产品临床研究时提供参考。

         

        Abstract: Resorbable adhesion barrier devices for use in abdominal and/or pelvic surgery are high-risk implantable medical devices. There are some difficulties in their clinical research. This article summarizes and analyzes the common problems of resorbable adhesion barrier devices for use in abdominal and/or pelvic surgery clinical studies from the perspective of technical review, in order to provide reference for Chinese manufacturers and investigators in the design of clinical studies and clinical research.

         

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