Phase IIB: Exploratory Clinical trials for The V Needle

IIB 期：V 针的探索性临床试验

• 批准号: 10017194
• 负责人: PATRICK J ROUSCHE
• 金额: $ 99.4万
• 依托单位: HEMOTEK
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-06-20 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10017194
• 关键词: Arteriovenous fistula; Benign; Blood; Blood Vessels; Blood flow; Butterflies; Cannulations; Caregivers; Cessation of life; Clinic; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Computer software; Contracts; Data; Detection; Devices; Dialysis patients; Dialysis procedure; Electronics; Elements; Ensure; Environment; Event; Excision; Feedback; Fill-It; Filtration; Frequencies; Funding; Health; Hemodialysis; Hemorrhage; Home environment; Hospitals; Human; Industry; Injury; Institutional Review Boards; Laboratories; Life; Manufacturer Name; Medical; Medical Device; Mind; Needles; North America; Patient Care; Patients; Performance; Phase; Procedures; Production; Provider; Pump; Running; Safety; Sample Size; Sampling; Savings; Series; Site; Skin; Small Business Innovation Research Grant; Venous; Work; arm; base; blood pump; care providers; clinical center; clinical implementation; commercialization; confirmatory clinical trial; cost; cost effective; design; engineering design; feasibility trial; first-in-human; follow-up; improved; innovation; meetings; member; novel; peace; pilot trial; pressure; research clinical testing

Hemodialysis (HD) is generally perceived as a safe, benign, procedure. But if venous needle dislodgement (VND) occurs during dialysis and the machine fails to detect it, within minutes the blood loss can be catastrophic, and even fatal. It is estimated that 400 dialysis patients suffer a dislodgement episode every week in the US. [3] In a Phase I/Phase II SBIR partnership with our clinical and medical device partners, Hemotek Medical Inc. has designed, developed, manufactured and characterized the V-Needle, the world’s first and only, inexpensive, needle-integrated, single-use AV fistula set that will protect patients from the dangers of bleed-out during needle dislodgement. The revolutionary V Needle looks and feels like a standard butterfly needle traditionally used for hemodialysis but includes a unique “skin-sensing” spring-loaded footplate element that can both immediately detect when a needle has dislodged and quickly occlude flow through the needle, dramatically limiting blood loss during dislodgment and initiating a life-saving critical automatic shut-off routine for the hemodialysis machine pump. It fills a currently unmet clinical need of efficiently protecting patients from the dangers of VND. The FDA has stipulated that a 510(k) application for the Hemotek V Needle must include human clinical trial data to validate the novel VND claims. In this Phase IIB project Hemotek proposes to partner with an industry-leading dialysis clinical trial provider and a leading worldwide needle manufacturer to perform the requested trial in-center. Results from the multi-site in-center trial proposed here will be used to attract strategic investors to inform and support more difficult, in-home/nocturnal clinical trials at a later date. The project aims are. Aim #1: Manufacture and Verification of Clinical Samples Aim #2: Clinical Study I: First-in-Man Feasibility Trial Aim #3: Clinical Study II: Confirmatory Clinical Trial (25 patients) Innovation: Hemotek’s 510(k)-approved V-Needle will be one of the most innovative disposable devices in the dialysis market place. Health Relevance: Automated shut off of HD machines during a VND occurrence using the V-Needle is expected to reduce the frequency of significant and serious events related to patient injury or death. Commercial Relevance: By partnering with world hemodialysis leaders, Hemotek ensures that the V-Needle will have maximum visibility for eventual commercialization.

血液透析（HD）通常被认为是一种安全、良性的手术。但是，如果在透析过程中发生静脉针头脱位（VND），而机器没有检测到，几分钟内失血可能是灾难性的，甚至是致命的。据估计，在美国，每周有400名透析患者出现排尿。在与我们的临床和医疗设备合作伙伴的I/ II期SBIR合作中，海默泰医疗公司设计、开发、制造并鉴定了V-Needle，这是世界上第一个也是唯一一个价格低廉、针头集成、一次性使用的房内瘘套装，将保护患者免受针头脱落时出血的危险。革命性的V针外观和感觉就像传统用于血液透析的标准蝴蝶针，但它包括一个独特的“皮肤感应”弹簧式底板元件，可以立即检测针头是否脱落，并迅速阻塞针头的血流，极大地限制了针头脱落过程中的失血，并启动了挽救生命的关键自动关闭血液透析机泵。它填补了目前未满足的有效保护患者免受VND危险的临床需求。FDA规定，hemtek V针的510(k)申请必须包括人体临床试验数据，以验证新的VND声明。在这个IIB期项目中，海默泰克建议与一家行业领先的透析临床试验提供商和一家全球领先的针头制造商合作，在中心进行所要求的试验。这里提出的多地点中心试验的结果将用于吸引战略投资者，以便在以后的日期为更困难的家庭/夜间临床试验提供信息和支持。该项目的目标是。目标#1：临床样品的制造和验证目标#2：临床研究I：首次人体可行性试验目标#3：临床研究II：验证性临床试验（25例患者）创新：hemtek的510(k)批准的V-Needle将成为透析市场上最具创新性的一次性设备之一。与健康相关：在VND发生期间，使用V-Needle自动关闭HD机器有望减少与患者受伤或死亡相关的重大和严重事件的频率。商业意义：通过与世界血液透析领导者的合作，海默泰克确保V-Needle在最终的商业化中具有最大的知名度。