CERVICAL CANCER DIAGNOSIS BY COLPOPROBE TM

第一阶段的结果表明，一种非接触式光学装置， ColpoProbe，在分期方面取得了与病理不相上下的结果 癌前疾病在人类宫颈的发展。科尔波探案 照亮组织，记录从组织返回的光并关联 荧光和背向散射到其组织病理学数据库。这个 最终目标是一种商业设备，为医生提供 实时体内病理学。第二阶段计划旨在改善 并确定其临床疗效。各种光学器件 读数将取自200名患者，巴氏染色阳性 涂片，在贝丝以色列医院。第一阶段算法将是 改进了。训练集将使用不同的方法进行装箱和测试 统计技术。光学读数将从宫颈取走 对健康志愿者的影响，以确定醋酸的应用效果 和月经周期。我们还将调查ColpoProbe是否可以 确定是否存在人乳头瘤病毒。一则广告 ColpoProbe承诺以以下成本为代价减少5亿美元 从阳性的巴氏涂片。这些节省将来自 活组织检查和转诊次数减少。第三阶段基金为 在实现第二阶段目标后得到保障。 建议的商业应用：有几个领域可以 成功的ColpoProbe将在临床上有用。A ColpoProbe(TM)，在 扫描宫颈，将给出所需的确定 医生解决非典型(ASCUS)造成的不确定性 报告情况。该设备将进一步促进对以下对象的“查看并治疗”选项 高级别皮损和重复就诊依从性为 很可能很穷。

The phase I results show that a non contact optical device, the ColpoProbe , achieved outcomes comparable with pathology, in staging pre-cancerous disease development in the human cervix. The ColpoProbe illuminates tissue, records light returned from the tissue and correlates fluorescence and backscatter to its histopathology database. The ultimate objective is a commercial device providing the physician with real time in-vivo pathology. The phase II program aims to improve the current device and determine its clinical efficacy. A variety of optical readings will be taken from two hundred patients, with positive Pap smears, at the Beth Israel Hospital. The Phase I algorithm will be improved. A training set will be crated and tested using various statistical techniques. Optical readings will be taken from the cervices of healthy volunteers to determine the effect of acetic acid application and the menstrual cycle. We will also investigate if the ColpoProbe can determine the presence of human papilloma viruses. A commercial ColpoProbe promises a half billion dollar reduction at the costs of follow up from a positive Pap smear. These savings will result from a reduction in the number of biopsies and referrals. Phase III funds are secured upon achieving the Phase II goals. PROPOSED COMMERCIAL APPLICATION: There are several areas where a successful ColpoProbe would be clinically useful. A ColpoProbe(TM), in scanning the cervix, would give the determination needed for the physician to resolve the uncertainty created by the atypical (ASCUS) report. The device will further facilitate the "see and treat" option for high-grade lesions and with patients where repeat visit compliance is likely to be poor.