Development of a non-instrumental Prothrombin Time test

非仪器凝血酶原时间测试的开发

• 批准号: 6442849
• 负责人: Wai Tak Law
• 金额: $ 40万
• 依托单位: PORTASCIENCE, INC.
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-05 至 2004-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6442849
• 关键词: bioengineering /biomedical engineering; biomedical equipment development; blood flow measurement; clinical trials; consumable /disposable biomedical equipment; home health care; human subject; human tissue; material; patient monitoring device; patient oriented research; prothrombin time; thromboplastin

DESCRIPTION (provided by applicant): Development of a disposable non-instrumented prothrombin time (PT) test for home use is proposed. Phase I data using flow channels built with precision woven fabric demonstrated the potential of the proposed test device. The blood flow endpoints formed due to clotting were repeatable, easy to read, and showed good correlation between PT and bar length. A simple and accurate disposable device is potentially a powerful tool to help patients monitor their PT at home. The specific objectives of this research are to: 1) finalize the design of the scale-up prototype device, 2) develop protocols to obtain scale-up and pilot production devices, 3) conduct clinical trials to evaluate the quality of the devices, and 4) submit data for FDA market approval. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE

描述（由申请人提供）：一次性产品的开发 建议家庭使用非仪器凝血酶原时间 (PT) 测试。第一阶段 使用精密机织织物构建的流道的数据证明了 所提出的测试设备的潜力。血流终点的形成是由于 凝血结果可重复、易于读取，并且与 PT 之间显示出良好的相关性 和杆长度。一个简单而准确的一次性设备可能是 帮助患者在家监测 PT 的强大工具。 本研究的具体目标是： 1）完成设计 放大原型装置，2) 开发协议以获得放大和中试 生产设备，3）进行临床试验来评估产品的质量 设备，以及 4) 提交数据以供 FDA 市场批准。 拟议的商业应用：不可用