SCREENING DEVICE FOR DETECTING SMALL ACOUSTIC TUMORS

描述：(改编自申请者摘要)：准确、早期发现 用标准的听性脑干反应诊断小型听神经瘤是困难的 (ABR)措施。因此，昂贵的捷运现在被用来筛查病人 疑似得了肿瘤。然而，大多数接受筛查的人没有 肿瘤。我们的长期目标是开发一种紧凑型、高性价比的 基于堆积ABR的筛分装置，一种新开发的ABR方法 检测微小的听神经瘤。这台设备将确保病人的成像。 同时大幅减少非肿瘤患者的影像。 在第一阶段，我们(1)证明了叠加ABR方法检测到的小 在大型临床中具有极好的敏感性和良好的特异性的肿瘤 人口，以及(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)优化堆叠ABR方法，以 增加其临床实用性，(2)将该方法纳入到用户友好的 (3)对优化方法进行了验证，并对样机进行了评估 一项多中心研究。因此，在第二阶段，一个商业上可行的原型使用 将开发、彻底测试优化的堆叠ABR算法，并 独立验证。这项工作对我们的第三阶段目标至关重要 开发用户友好、经济高效、可商业化的临床 用于堆叠ABR的系统。 建议的商业应用： 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