Portable Imaging Device for Prostate Cancer Detection

描述（由申请人提供）：该项目的长期目标是向市场推出一种用于前列腺癌筛查的新工具，即前列腺机械成像仪（PMI），该成像仪可提供前列腺的真实的实时三维重建，捕获其几何和机械特征，并有助于检测组织异常。目前的PMI原型已经经历了硬件和软件开发的几个进展，最终的设备概念在模型实验和临床研究中得到了验证，并取得了可喜的成果。ProUroScanTM是在拟议项目过程中开发、临床测试并提交FDA批准的第一个PMI商业器械。ProUroScanTM获得的数字记录可用于记录可触及的前列腺异常并监测疾病随时间的进展。ProUroScanTM将包括一个经直肠探头，包括力传感器阵列和一个运动跟踪系统，一个紧凑的电子单元，带有一个电子板，通过USB端口从具有触摸屏功能的笔记本电脑和一个无线彩色打印机供电。作为一个单独的组件，将设计和构建用于触觉传感器测试、调整和校准的自动校准设置。拟议项目的具体目标包括PMI硬件和软件改进。硬件开发将包括PMI经直肠探头和数据采集板的几项技术改进。用于前列腺三维实时重建和结节检测的软件将得到完善和验证。将投入大量的努力，以确保PMI开发的活动和最终设计符合监管要求。商业化前工程的重点是完成设计历史文件、验证、确认和安全认证测试。两阶段临床研究将在Robert Wood约翰逊医学中心（新不伦瑞克，NJ）和VA医学中心（Minneapolis，MN）进行，以记录系统安全性和有效性。所有拟议活动的重点和赠款的终点将是准备和提交PMA申请，以获得FDA对PMI的批准。Artann与上市医疗器械公司ProUroCare建立了核心合作伙伴关系，以确保PMI的商业化成功。ProUroCare已承诺为PMI技术的监管许可和商业化提供必要的财务和管理资源，以补充NIH对该项目的支持。存在500亿美元的前列腺相关市场，估计有4000万至6000万成年男性患有一种或多种前列腺病症。行业分析师认为，只有10 - 15%的事件被报告，强调迫切需要新的筛选技术。该项目的目标是开发ProUroScanTM，这是一种具有成本效益、便携式和易于使用的成像设备，用于检测和记录可触及的前列腺异常并随时间监测疾病进展。

DESCRIPTION (provided by applicant): The long-term goal of the project is to bring to the market a new tool for prostate cancer screening, the Prostate Mechanical Imager (PMI), which provides real time 3-D reconstruction of prostate capturing its geometrical and mechanical characteristics and aids in detecting tissue abnormalities. The current PMI prototype has undergone several progressions of hardware and software development leading to the final device concept validated in model experiments and in clinical studies which have yielded promising results. ProUroScanTM is the first PMI commercial device to be developed, clinically tested and submitted for FDA approval in the course of the proposed project. Digital records obtained by ProUroScanTM could be used to document palpable prostate abnormalities and to monitor disease progression over time. The ProUroScanTM will include a transrectal probe comprising force sensor arrays and a motion tracking system, a compact electronic unit with single electronic board powered through USB port from a laptop with touch screen capability and a wireless color printer. As a separate component, an automatic calibration setup for tactile sensor testing, tuning and calibration will be designed and built. Specific aims of the proposed project include PMI hardware and software refinements. The hardware development will include several technological improvements in the PMI transrectal probe and data acquisition board. Software for prostate 3-D real-time reconstruction and nodule detection will be refined and validated. Substantial amount of effort will be committed to assure the activities and resulting design of the PMI development comply with regulatory requirements. A key focus of pre-commercialization engineering will be on completing the design history file, verification, validation and safety certification testing. Two-stage clinical studies will be conducted at the Robert Wood Johnson Medical Center (New Brunswick, NJ) and at VA Medical Center (Minneapolis, MN) to document system safety and efficacy. The focal point of all proposed activities and the endpoint of the grant will be preparation and submission of the PMA application for the FDA approval of PMI. The core partnership was established between Artann and ProUroCare, publicly traded medical device company, to ensure commercialization success of the PMI. ProUroCare has committed necessary financial and managerial resources for regulatory clearance and commercialization of the PMI technology to complement NIH support of the project. There is a $50 billion prostate-related market with estimated 40 - 60 milion adult males suffering from one or more prostate conditions. Industry analysts believe that only 10 - 15% of incidents are reported, stressing the urgent need for new screening technologies. The goal of this project is to develop ProUroScanTM, a cost- effective, portable and easy-to-use imaging device for detecting and documenting palpable prostate abnormalities and monitoring disease progression over time.