Colonoscope Force Monitor

结肠镜力监测仪

• 批准号: 7219562
• 负责人: Armen Sarvazyan
• 金额: $ 47.97万
• 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 2009-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7219562
• 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(申请人提供)：该项目的目标是开发结肠镜检查力监测器(CFM)，这是一种安装在结肠镜检查轴上的手持式附件，为医生提供关于结肠镜检查过程中施加的力和扭矩的实时反馈。CFM旨在改善对内窥镜医生的培训，通过对专家技能的量化表征来建立执行结肠镜检查的最佳实践，并通过使其更安全和更舒适来增强结直肠癌筛查程序。改进培训和制定最佳做法将有助于结直肠癌筛查的安全性和有效性。此外，CFM的使用可以减少或在某些情况下取消结肠镜检查中深度镇静的使用，并降低检查的总体成本。到目前为止，CFM原型的开发已经超越了第一阶段的原始目标。三代CFM-a原型是由经验丰富的内窥镜专家设计、制造并在体模测试中得到验证的。该项目第二阶段的目标是建造和测试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：纽约市布朗克斯的Montefiore医学中心和华盛顿特区退伍军人事务医学中心的临床研究所。在第二阶段结束时，将开发CFM的全性能试生产原型，将对CFM在培训和持续教育方面的效果进行临床试验，并将根据法规要求准备必要的工程文档。结肠镜检查力监测器(CFM)是一种手持设备，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。这项技术旨在改善结肠镜检查培训，建立最佳实践，并通过使结直肠癌筛查程序更安全、更舒适来改进程序。