Trial Information

Phase I Study for Evaluation of Handheld Colonoscopy Force Monitor by Expert Endoscopists in the Performance of Colonoscopy

Colonoscopy requires a skilled endoscopist to use visual and tactile information to advance
and withdraw the instrument through a series of fixed and stationary loops. To develop and
maintain the skills necessary to perform colonoscopy safely and effectively requires
extensive training and ongoing education. Quantification of tactile information provides
the opportunity to understand the "feel" used by the endoscopist to perform colonoscopy.
The identification of force application patterns has the potential to enhance training and
improve performance. CFM™ is a handheld device that uses load cells to transform applied
force to electric signals and to transmit wirelessly the signal to a computer for storage
and visual display. The device is designed so that the endoscopist maintains a conventional
hand position and uses an electronically controlled grip and release mechanism to fix the
position on the instrument. Six expert endoscopists will use the CFM™ to perform
colonoscopy in 30 patients. The data will be recorded and analyzed for differences by
patient characteristics(e.g. gender, age, pain sensation, surgical history) and by
endoscopist.