Research Project
7219562
[unreadable] 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 [unreadable]-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. [unreadable] [unreadable] [unreadable]
