Colonoscope Force Monitor

描述（由申请人提供）：该项目的目标是开发结肠镜力监测器（CFM），这是一种安装在结肠镜轴上的手持附件，可为医生提供结肠镜检查过程中施加的力和扭矩的实时反馈。CFM旨在改善内窥镜医师的培训，通过对专家技能的定量描述，建立结肠镜检查的最佳实践，并通过使其更安全、更舒适来加强结直肠癌筛查程序。改进培训和发展最佳做法将有助于大肠癌筛查的安全性和有效性。此外，CFM的使用可以减少或在某些情况下消除结肠镜检查中深度镇静的使用，并降低检查的总成本。迄今为止，CFM原型的开发已经超越了第一阶段的最初目标。三代CFM-a原型由经验丰富的内窥镜医师设计、制造并在模型测试中进行验证。该项目第二阶段的目标是建立和测试CFM -原型。CFM的性能将首先在结肠镜模拟器测试中进行评估。然后，临床研究将在两个合作组织同时进行：在第二阶段结束时，将开发CFM的全性能预生产原型，对CFM对培训和持续教育的影响进行临床试验，并根据监管要求准备必要的工程文件。结肠镜力监测器（CFM）是一种手持式设备，用于测量和显示医生在结肠镜检查过程中施加的扭矩和推/拉力。该技术旨在改善结肠镜检查培训，建立最佳实践，并通过使其更安全、更舒适来改进结直肠癌筛查程序。

DESCRIPTION (provided by applicant): The goal of this project is to develop a Colonoscopy Force Monitor (CFM), a handheld attachment mounted on the colonoscope shaft which provides a physician with real-time feedback on the force and torque applied during colonoscopy. The CFM is designed to improve the training of endoscopists, establish best practices for performing colonoscopy by quantitative characterization of expert's skill, and enhance colorectal cancer screening procedures by making them safer and more comfortable. Improved training and development of best practices will contribute to the safety and effectiveness of colorectal cancer screening. In addition, the use of CFM could reduce or, under some circumstances, eliminate the use of deep sedation for colonoscopy, and lessen the overall cost of the exam. The CFM prototype development performed to date has advanced beyond the original objectives of Phase I. Three generations of the CFM-a prototypes were designed, built, and validated in phantom testing by experienced endoscopists. The objectives of Phase II of this project are to build and test the CFM ¿-prototype. The CFM performance will be first assessed in colonoscopy simulator tests. Then, clinical studies will be conducted simultaneously at two partnering organizations: Montefiore Medical Center, Bronx, NYC, and the Institute for Clinical Research at the Veterans Affairs Medical Center, Washington, D.C. At the end of Phase II, the full-performance, preproduction prototype of CFM will be developed, a clinical trial of the effect of CFM on training and ongoing education will be performed, and necessary engineering documentation will be prepared in accordance with regulatory requirements. Colonoscopy Force Monitor (CFM) is a handheld device measuring and displaying the torque and push/pull forces applied by a physician during colonoscopy. The technology is designed to improve colonoscopy training, establish best practices, and improve colorectal cancer screening procedures by making them safer and more comfortable.