Real-Time VLS Detection of Colon Ischemia in AAA Repair

描述（由申请人提供）：我们在I期挽救了患者的生命，并达到或超过了所有I期里程碑。我们现在建议在三个领先的临床中心（斯坦福大学，加州大学，弗吉尼亚州）进行一项扩大试验来验证和扩展这些结果。该II期SBIR提案解决了检测与腹主动脉瘤（AAA）修复相关的结肠缺血的需求，这是AAA修复的致命并发症。50岁以上的成年人中有5%的人患有腹动脉瘤，其修复或破裂是美国第13大死亡原因。AAA修复的致命并发症是结肠缺血（1-2%的肠缺血率，2004年纽约大学、纽约州立大学和DREAM研究证实）。在AAA修复后出现中重度结肠缺血的患者中，大多数在出院前死于不可逆的结肠梗死。只有在数小时内发现并治疗缺血，早期手术干预才能改善预后。一旦结肠死亡，病人生病，就来不及修复了。在此试验之前，没有可靠的早期检测技术存在。此外，2005年的新研究表明，AAA破裂后支架修复可使死亡率降低一半，但会导致频繁的结肠缺血，这表明AAA破裂患者可能受益于监测。在第一阶段，我们开发并测试了直肠探针来检测急性缺血，并改变了结果。

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 patient becomes ill, it is too late for repair. Prior to this trial, no reliable early detection technique existed. Moreover, new 2005 studies show that stent repair AFTER rupture of an AAA cuts mortality by half, but results in frequent colon ischemia, suggesting patients with ruptured AAA may benefit from monitoring. 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 less than 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.