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. ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44DK068936-02A1
Application #
7219562
Study Section
Special Emphasis Panel (ZRG1-SSMI-K (10))
Program Officer
Densmore, Christine L
Project Start
2004-08-01
Project End
2009-05-31
Budget Start
2007-06-01
Budget End
2008-05-31
Support Year
2
Fiscal Year
2007
Total Cost
$479,687
Indirect Cost
Name
Artann Laboratories, Inc.
Department
Type
DUNS #
959147026
City
Trenton
State
NJ
Country
United States
Zip Code
08618
Korman, Louis Y; Haddad, Nadim G; Metz, David C et al. (2014) Effect of propofol anesthesia on force application during colonoscopy. Gastrointest Endosc 79:657-62
Cheng, Wu-Bin; Di, Yun-Yun; Zhang, Edwin M et al. (2013) Modeling and in vitro experimental validation for kinetics of the colonoscope in colonoscopy. Ann Biomed Eng 41:1084-93
Korman, Louis Y; Brandt, Lawrence J; Metz, David C et al. (2012) Segmental increases in force application during colonoscope insertion: quantitative analysis using force monitoring technology. Gastrointest Endosc 76:867-72
Korman, Louis Y; Egorov, Vladimir; Tsuryupa, Sergey et al. (2010) Characterization of forces applied by endoscopists during colonoscopy by using a wireless colonoscopy force monitor. Gastrointest Endosc 71:327-34