NEW ACOUSTIC DEVICE FOR CLINICAL BRAIN TRAUMA DIAGNOSIS

描述：(逐字摘自申请者摘要)激活信号 技术公司(AST)建议在第二阶段推进开发 其成功测试的非侵入性脑评估监测器(BAM) 30名处于第一阶段的患者AST的合作伙伴R.Adams休克创伤中心 (STC)将进行一项扩大的临床研究 旨在证明BAM适应症与传统的 颅内病理检查结果。具体地说，AST将改进传感器 和电子学在应用上更加通用，并增加信号处理 以提高决策的准确性和自动化程度。激活信号将测试 对健康志愿者的系统进行升级，直到满意时产生零错误 阳性，然后将生产并交付两个单位给STC用于临床 学习。STC将评估大约。300例颅脑损伤患者使用BAM 入场后，跟踪大约。100个人在整个过程中接受侵入性监控 他们的待遇。BAM指征与临床的相关性研究 对后续干预和结果的入院需求进行评估。vt.在.的基础上 第二阶段的结论是，这种新的非侵入性技术将实现 经过统计验证的操作准确性，目前仅适用于 侵入性技术或CAT/MRI扫描，从而显著增加 可获得性和降低脑损伤评估的成本。 建议的商业应用：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