Research Project
8417602
DESCRIPTION (provided by applicant): Colonoscopy is the preferred method to screen for colorectal cancer, a disease that afflicts 115,000 new patients a year. Several million screening, diagnostic and therapeutic colonoscopies are performed each year in U.S. hospitals and ambulatory surgery centers. However, colonoscopy remains a highly operator dependent activity and no clear definition of skill exists. There is very limited understanding of the methods used by endoscopist to execute a safe and effective colonoscopy and there is a significant need for technology to improve training and to provide a means of assuring that examinations are performed in a safe and effective manner. The Colonoscopy Force Monitor (CFM), which is being developed under this grant, appears to fill the clinical void. CFM is a wireless force-measuring handle attached to the colonoscope shaft to provide a physician with a real-time feedback on the force and torque applied during colonoscopy. The CFM is designed to improve training of endoscopists and establish best practices for performing colonoscopy by quantitative characterization of examiner performance. 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 main objective of this Phase II Competing Renewal grant is to advance the CFM to the pre-manufacturing level; to complete clinical studies required for the PMA application processes; and to prepare regulatory submission for the market clearance of the CFM technology. In Phase II of this project we developed the 2-prototype CFM hardware and software as a basis for a pre- - production prototype, built a preproduction prototype and obtained clinical feedback on its functionality; characterized CFM use by experienced endoscopists and defined CFM capability for colonoscopy training. Most of the technical requirements to the CFM technology including adequate range and accuracy of force measurement, convenient grip, disinfection and automated engage/disengage mechanism were implemented and tested in the CFM prototype. Laboratory validation tests and endoscopists' feedback confirmed the functionality of the CFM. Clinical studies performed by experienced endoscopists in community and academic centers and trainees confirmed the clinical usefulness of CFM as practical tool that for the first time allows comprehensive characterization of a critical aspect of endoscopist behavior. The technical tasks of the current project will be related to the manufacturability aspects of CFM, further optimizing the device to address issues raised by the users during clinical testing of the Phase II prototype and development of a classifier system to efficiently characterize the colonoscope manipulation pattern. Large multi-site clinical study that will engage prominent academic institutions with the endoscopy training centers will be performed to collect evidence of clinical safety and efficacy for FDA review. Engineering documentation and all regulatory compliance activities for regulatory filing will be completed.
