Real-Time VLS Detection of Colon Ischemia in AAA Repair

描述(申请人提供)：我们在第一阶段挽救了患者的生命，达到或超过了所有第一阶段的里程碑。我们现在建议在3个领先的临床中心(斯坦福大学，大学)进行扩大试验，以验证和推广这些结果。弗吉尼亚州加利福尼亚州)。这项第二阶段的SBIR建议解决了与腹主动脉动脉瘤(AAA)修复相关的结肠缺血检测的需要，AAA修复是AAA修复的致命并发症。在50岁以上的成年人中，5%的人会发现腹主动脉瘤，其修复或破裂是美国第13大主要死亡原因。AAA修复的致命并发症是结肠缺血(1-2%的肠道缺血率，在2004年纽约大学、纽约州立大学和Dream Study的研究中得到证实)。在AAA修复后出现中到重度结肠缺血的患者中，大多数人在出院前死于不可逆转的结肠梗死。只有当缺血在数小时内被发现和治疗时，早期手术干预才能改善预后。一旦结肠死亡和病人护理。在第一阶段，我们开发并测试了一种直肠探头来检测急性缺血，并改变了结果。 I期结果：患者无探头患者无探头 I期研究的患者数量38名研究患者526名对照 ICU天数(有缺血的患者)ICU 2天ICU 29天(p&lt；0.001) 死亡率(患有缺血的患者)0%死亡55%死亡 这项第二阶段(R44)建议的具体目标是：(1)制造符合FDA标准的商业化探头，(2)将R43研究扩展为一项关键的NIH-阶段Ill-Type多中心试验，涉及500名接受AAA修复的患者，验证结肠监测在5项结果指标上的临床效果。如果成功，探测器将实现商业化。Spectrs的创始人已经创建了其他生物技术公司并将其上市(Xenogen)，Spectrs本身正在销售一种由SBIR支持的用于麻醉的产品。

DESCRIPTION (provided by applicant): We saved patient lives in Phase I, and met or exceed all Phase I milestones. We now propose to verify and extend these results in an expanded trial at 3 leading clinical centers (Stanford, Univ. of California, VA). This Phase II SBIR proposal addresses the need to detect colon ischemia associated with the repair of Abdominal Aortic Aneurysm (AAA), a lethal complication of AAA repair. An abdominal aneurysm is found in 5% of adults over 50, and its repair or rupture is the 13th leading cause of death in the U.S. A lethal complication of AAA repair is colon ischemia (1-2% rate of ischemia to the gut, confirmed in 2004 studies from NYU, SUNY, and DREAM study). Of those developing moderate to severe colon ischemia after AAA repair, the majority die before leaving the hospital of irreversible colon infarction. Early surgical intervention improves outcome ONLY if the ischemia is detected and treated within hours. Once the colon dies and the patientnitoring. In Phase I, we developed and tested a rectal probe to detect acute ischemia, and changed outcome. PHASE I RESULTS: PATIENTS w/ PROBE PATIENTS w/o PROBE Number of Patients in Phase I Study 38 Study Patients 526 Controls ICU Days (patients w/ischemia) 2 Days in ICU 29 Days in ICU (p<0.001) Death Rate (patients w/ischemia) 0% Died 55% Died The specific aims of this Phase II (R44) proposal are: (1) to manufacture a commercializable probe to FDA standards, (2) to extend the R43 study into a pivotal NIH-Phase Ill-Type multi-center trial of 500 patients undergoing AAA repair, validating the clinical efficacy of colon monitoring on 5 outcome measures. If successful, the probe will be commercialized. Spectros founders have already founded and taken other biotech firms public (Xenogen), and Spectros itself is selling an SBIR-supported product for anesthesia use.