Colonoscope Force Monitor

结肠镜力监测仪

• 批准号: 7416677
• 负责人: Armen Sarvazyan
• 金额: $ 41.73万
• 依托单位: ARTANN LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-08-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7416677
• 关键词: Absence of pain sensation; Algorithms; Ambulatory Surgical Procedures; Analgesics; Anatomy; Clinical; Clinical Data; Clinical Research; Clinical Trials; Colon; Colonoscopes; Colonoscopy; Colorectal Cancer; Computer software; Continuing Education; Depth; Development; Devices; Diagnostic; Disease; District of Columbia; Documentation; Education; Effectiveness; Engineering; Feedback; Freezing; Generations; Genus Cola; Goals; Hospitals; Institutes; Laboratories; Lead; Learning; Measures; Medical center; Methods; Metric; Monitor; Names; Numbers; Outcome Measure; Pain; Patients; Perforation; Performance; Phase; Physicians; Principal Investigator; Procedures; Production; Quality Control; Reporting; Research; Research Ethics Committees; Safety; Screening procedure; Sedation procedure; Series; Software Design; Solutions; Standards of Weights and Measures; Surface; System; Techniques; Technology; Testing; Therapeutic; Time; TimeLine; Torque; Training; Tube; Validation; Variant; Veterans; Visual; colorectal cancer screening; cost; design; engineering design; experience; improved; prototype; quality assurance; skills

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.

描述（由应用程序提供）：该项目的目的是开发结肠镜检查监测仪（CFM），这是安装在结肠镜轴上的手持式附件，该手持式附件可为实物提供对结肠镜检查过程中施加的力和扭矩的实时反馈。 CFM旨在改善内窥镜的训练，通过定量对专家技能的定量表征进行结肠镜检查，建立最佳实践，并通过使它们更安全，更舒适，从而增强结直肠癌筛查程序。改进的最佳实践培训和发展将有助于结直肠癌筛查的安全性和有效性。此外，CFM的使用可能会减少或在某些情况下，消除对结肠镜检查的深层镇静，并降低考试的整体成本。迄今为止执行的CFM原型开发已超出了第一阶段的原始对象。经验丰富的内窥镜医生在幻影测试中设计，构建和验证了三代CFM-A原型。该项目第二阶段的目标是构建和测试CFM� -Prototype。 CFM性能将首先在结肠镜模拟器测试中评估。然后，将在两个合作组织同时进行临床研究：纽约市蒙特菲奥尔医学中心，以及华盛顿特区退伍军人事务医学中心的临床研究研究所，在第二阶段结束时，全面的，全面的，全面的，在CFM的临床培训，培训CFM的临床培训，培训CFM的培训，并在CFM上进行了培训，并在CFM上进行了培训。根据监管要求准备。结肠镜检查力监测器（CFM）是一种手持设备，可在结肠镜检查过程中测量和显示由物理施加的扭矩和推动力。该技术旨在改善结肠镜检查训练，建立最佳实践并通过使其更安全，更舒适来改善结直肠癌筛查程序。