NEW ACOUSTIC DEVICE FOR CLINICAL BRAIN TRAUMA DIAGNOSIS

描述：（逐字引用申请人的摘要）有源信号 技术公司(AST)建议在第二阶段， 其非侵入性大脑评估监测器（BAM）， 在第一阶段的30个病人身上。AST的合作伙伴，R。亚当斯休克创伤中心 (STC)在马里兰州大学，将进行一项扩大的临床研究 旨在证明BAM指示与传统 颅内病理学指标。具体来说，AST将改进传感器 和电子学在应用中更加通用，并增加信号处理 以提高准确性和自动化决策。主动信号将测试 升级系统对健康志愿者，直到满意它产生零假 阳性，然后将生产并交付两个单位给STC用于临床 study. STC将评估大约。300名头部受伤的患者使用BAM 在入场和轨道接近。100人全程接受侵入性监测 他们的待遇。将在BAM适应症和临床之间建立相关性 评估后续干预的入院需求和结果。后 第二阶段的结论，这种新的非侵入性技术将实现一个 统计证明的操作准确性，目前仅适用于 侵入性技术或CAT/MRI扫描，从而显著增加 降低脑损伤评估的成本。 拟议商业应用：不可用

DESCRIPTION: (Verbatim from the Applicant's Abstract) Active Signal Technologies, Inc. (AST) proposes to advance, during Phase II, the development of its non-invasive Brain Assessment Monitor (BAM) that was successfully tested on 30 patients during Phase I. AST's partner, the R. Adams Shock Trauma Center (STC) at the University of Maryland, will conduct an expanded clinical study designed to demonstrate correlations of the BAM indications with traditional measures of intracranial pathology. Specifically, AST will refine the sensor and electronics to be more universal in application, and add signal processing to increase accuracy and automate decision making. Active Signal will test the upgraded system on healthy volunteers until satisfied it produces zero false positive, and then will produce and deliver two units to STC for the clinical study. The STC will evaluate approx. 300 head-injured patients using the BAM upon admission and track approx. 100 receiving invasive monitors throughout their treatment. Correlations will be made between BAM indications and clinical evaluation on admission needs for subsequent interventions and outcome. Upon Phase II's conclusion this new non-invasive technology will achieve a statistically-demonstrated operational accuracy, currently available only with invasive techniques or CAT/MRI scans, thereby significantly increasing accessibility and reducing costs of brain-injury assessment. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE