SCREENING DEVICE FOR DETECTING SMALL ACOUSTIC TUMORS

描述：（改编自申请人摘要）：准确和早期检测 小的听神经瘤很难用标准的听性脑干反应检查 (ABR)措施因此，昂贵的磁共振成像现在被用来筛选病人 怀疑有肿瘤。然而，大多数接受筛查的人没有 肿瘤的我们的长期目标是开发一种紧凑型高性价比 Stacked ABR是一种新开发的ABR方法， 检测小的听神经瘤该设备将确保患者成像 同时大大减少非肿瘤患者的成像。 在第一阶段，我们（1）证明了叠加ABR方法检测到小 在大型临床肿瘤中具有出色的敏感性和良好的特异性， 人口，（2）开发了基本的硬件和软件组件， 商业设备。在第二阶段，我们将（1）优化Stacked ABR方法， 增加其临床实用性，（2）将该方法纳入用户友好的 原型，以及（3）验证优化方法并评估原型 多中心研究。因此，在第二阶段，一个商业上可行的原型， 将开发优化的Stacked ABR算法，进行彻底的测试， 独立验证。这项工作对我们的第三阶段目标至关重要， 开发一种用户友好的具有成本效益的商业化临床 Stacked ABR系统。 拟定商业应用： 不可用

DESCRIPTION: (Adapted from applicant's abstract): Accurate and early detection of small acoustic tumors is difficult with standard Auditory Brainstem Response (ABR) measures. As a result, expensive MRt is now used to screen patients suspected of having a tumor. However, most of those screened do not have tumors. Our long-term goal is the development of a compact cost-efficient screening device based on the Stacked ABR, a newly-developed ABR method for detecting small acoustic tumors. This device will insure imaging of patients with tumors while substantiafly reducing imaging of non-tumor patients. In Phase I, we (1) demonstrated that the Stacked ABR method detected small tumors with excellent sensitivity and good specificity in a large clinical population, and (2) developed basic hardware and software components for the commercial device. In Phase II, we will (1) optimize the Stacked ABR method to increase its clinical utility, (2) incorporate the method in a user-friendly prototype, and (3) validate the optimized method and evaluate the prototype in a multi-center Study. Thus, in Phase II, a commercially-viable prototype using optimized Stacked ABR algorithms will be developed, thoroughly tested, and independently validated. This work is crucial to our Phase III goal of developing a user-friendly cost-efficient commercially-available clinical system for the Stacked ABR. PROPOSED COMMERCIAL APPLICATION: Not Available