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IGF::OT::IGF Topic 090, Phase II, Devices to Close Ductus Arteriosus in Premature Infants IGF::OT::IGF

IGF::OT::IGF 主题 090，第二阶段，早产儿动脉导管闭合装置 IGF::OT::IGF

基本信息

批准号：
9581252
负责人：
PAUL LUBOCK
金额：
$ 199.96万
依托单位：
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-07-03 至 2019-07-02
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9581252
关键词：
Animal Experiments Animal Model Animals Caring Case Report Form Catheters Chronic Clinical Clinical Protocols Clinical Trials Collaborations Development Plans Device or Instrument Development Devices Documentation Ductus Arteriosus Elements Equipment Malfunction Failure Fatigue Freezing Geometry Goals Human Implant Informed Consent Intramural Research Investigation Laboratories Laboratory Research Licensing Marketing Maryland Mechanics Modeling Morbidity - disease rate National Heart, Lung, and Blood Institute Patent Ductus Arteriosus Peripheral Phase Premature Infant Preparation Reporting Research Design Risk Specific qualifier value Sterility System Testing Travel United States National Institutes of Health base biomaterial compatibility clinical development clinical material cost design hemodynamics in vivo meetings minimally invasive mortality payment prototype research and development research clinical testing safety testing treatment strategy

项目摘要

Summary Premature infants with hemodynamically significant patent ductus arteriosus suffer increased mortality and significant morbidity. A minimally invasive, catheter based treatment strategy would be attractive. Project Goals The goal of the project is to develop an implantable patent ductus arteriosus closure device to be safely delivered through the peripheral vasculature of a premature infant. First, a prototype would be developed and tested in animals, and ultimately a clinical-grade device would undergo regulatory development for clinical testing at NIH. Offerors are encouraged to include concrete milestones in their proposals, along with detailed research and development plans, risk analysis, and contingency plans, both for Phase I and Phase II. It is recognized that available animal models may not match the desired human in vivo geometry of the device. Offerors are advised to plan for travel to NHLBI in Bethesda Maryland, and are expected to plan meetings at project initiation, mid-project to determine what iteration is necessary, and at project completion.

总结具有血流动力学显著性动脉导管未闭的早产儿死亡率和发病率显著增加。微创、基于导管的治疗策略将是有吸引力的。项目目标该项目的目标是开发一种植入式动脉导管未闭闭合装置，通过早产儿的外周血管安全输送。首先，原型将在动物身上开发和测试，最终临床级设备将在NIH进行临床测试的监管开发。我们鼓励报价人在其建议书中包括具体的里程碑，沿着详细的研究和开发计划、风险分析以及第一阶段和第二阶段的应急计划。人们认识到，可用的动物模型可能与器械的预期人体体内几何形状不匹配。建议报价人计划前往马里兰州贝塞斯达的NHLBI，并计划在项目启动、项目中期和项目完成时举行会议，以确定需要进行哪些迭代。