《Chinese Journal of Rehabilitation Theory and Practice》 ›› 2019, Vol. 25 ›› Issue (4): 493-496.doi: 10.3969/j.issn.1006-9771.2019.04.023

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Requirements of Technical Review for Clinical Trial for Implantable Sacral Nerve Stimulation System

ZHANG Yu-jing1, LIAO Li-min2, LI Wei3, YAN Xiao-yan4, LIU Xiao-yan1, XU Wei1   

  1. 1.Center For Medical Device Evaluation, National Medical Products Administration, Beijing 100081, China
    2.China Rehabilitation Research Center, Beijing 100068, China
    3.Medical Research & Biometrics Center, National Center for Cardiovascular Diseases, Chinese Academy of Medical Diseases, Fuwai Hospital, Beijing 100037, China
    4.Peking University Clinical Research Institute, Beijing 100191, China
  • Received:2019-01-30 Revised:2019-03-07 Published:2019-04-20 Online:2019-04-24
  • Contact: XU Wei, E-mail: xuwei@cmde.org.cn

Abstract: The technical review for clinical trials of implantable sacral nerve stimulation system needs to focus on the basic principles of trials, clinical institutition and design elements of clinical trial protocols.

Key words: implantable sacral nerve stimulation system, clinical trail, technical review

CLC Number: