项目来源
国家重点研发计划(NKRD)
项目主持人
李建伟
项目受资助机构
中国人民解放军第三军医大学
立项年度
2017
立项时间
未公开
项目编号
2017YFC0110505
项目级别
国家级
研究期限
未知 / 未知
受资助金额
1400.00万元
学科
数字诊疗装备研发
学科代码
未公开
基金类别
未公开
关键词
手术机器人 ; 临床 ; 应用 ; Surgical robot ; clinical ; application
参与者
曹利
参与机构
中国人民解放军陆军军医大学
项目标书摘要：本课题任务目标为多孔腔镜手术机器人产品验证、注册及应用评价研究—技术报告主要研究内容包括 4 个方面：测试检验、临床试验、注册认证和应用评价，并分别达成如下目标:①依据产品标准(包括适用的国家标准、行业标准或者注册产品企业标准)对手术机器人及其部件进行测试检验，整机及部件通过权威测试检验，并获得检测报告。②依据《医疗器械临床试验规定》相关要求，进行临床试验，验证产品的安全性和有效性，产品通过临床试验，并获得临床试验报告。③依据医疗器械注册相关法规提交注册申请，整机获得医疗器械注册证 1 项，全维微创手术器械、高清 3D 双目内窥镜各获得医疗器械注册证 1 项。④以达芬奇手术机器人为参照，进行应用评价对比研究，发现本项目手术机器人的不足，用于指导产品的后续提升和改进，并获得应用对比评价研究报告。根据目前项目实施进度，目前已经完成标准制定及转化、制定临床试验计划及方案、完成产品注册策划等工作。
Application Abstract: The task of this project is the research on product validation,registration and application evaluation of porous cavity surgery robot.The main research contents of the technical report include four aspects:Test and inspection,clinical test,registration and certification and application evaluation,and the following goals are achieved respectively:① according to the product standards(including applicable national standards,industry standards or registered product enterprise standards),the operation robot is tested and registered according to the product standards(including applicable national standards,industry standards or registered product enterprise standards)And its components are tested and inspected.The whole machine and components pass the authoritative test and inspection,and obtain the test report ② according to the relevant requirements of the provisions on clinical trials of medical devices,carry out clinical trials to verify the safety and effectiveness of the products.The products pass the clinical trials and obtain the clinical trial reports.③ submit the registration application according to the relevant laws and regulations of medical device registration.The whole machine obtained one medical device registration certificate,and the full-dimensional minimally invasive surgical device and the high-definition 3D binocular endoscope each obtained one medical device registration certificate ④ with the reference of Leonardo da Vinci surgical robot,the comparative study of application evaluation was carried out,and the shortcomings of the surgical robot in this project were found,which was used to guide the follow-up promotion and improvement of the product,and the application comparative evaluation study report was obtained.According to the current project implementation schedule,the standard formulation and transformation,clinical trial plan and scheme,product registration planning and other works have been completed.
项目受资助省
重庆市
