Phase IIB: Exploratory Clinical trials for The V Needle

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脱位（VND），而机器未能检测到它，那么在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名透析患者发生脱位。[3]在与我们的临床和医疗器械合作伙伴Hemotek Medical Inc. V-Needle是世界上第一个也是唯一一个价格低廉、针集成、一次性使用的动静脉瘘套件，它将保护患者免受针脱落时出血的危险。革命性的V针外观和感觉都像传统上用于血液透析的标准蝶形针，但包括一个独特的“皮肤感应”弹簧加载踏板元件，可以立即检测到针头何时脱落并快速阻塞通过针头的血流，大大限制了脱落期间的失血，并启动血液透析机泵的救生关键自动关闭程序。它填补了目前尚未满足的有效保护患者免受VND危险的临床需求。FDA规定，Hemotek V针的510（k）申请必须包括人体临床试验数据，以确认新的VND声明。在该IIB期项目中，Hemotek建议与行业领先的透析临床试验提供商和全球领先的针头制造商合作，在中心内进行所要求的试验。本文提出的多中心临床试验的结果将用于吸引战略投资者，以便在以后为更困难的家庭/夜间临床试验提供信息和支持。该项目的目标是。目标一：临床样本的生产和验证目标#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：Hemotek的510（k）批准V型针将成为透析市场上最具创新性的一次性器械之一。健康相关性：在VND发生期间使用V型针自动关闭HD机器预计将降低与患者损伤或死亡相关的重大和严重事件的频率。商业相关性：通过与世界血液透析领导者合作，Hemotek确保V针在最终商业化中具有最大的可见性。

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.