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. Several expert endoscopists from multiple institutions will use
the CFM™ to perform colonoscopy. The data will be recorded and analyzed for differences by
patient characteristics(e.g. gender, age, pain sensation, surgical history) and by
endoscopist.

Inclusion Criteria:

- Male or female

- Age: 30-75 years

- ASA Class I or II

- All ethnic and racial groups will be included

Exclusion Criteria:

- Colonic pathology that in the opinion of the endoscopist could interfere with the
colonoscopy. Examples include: colonic stricture, poor preparation, obstructing
tumor.

- Specific pathology that would limit the extent of examination

- ASA class 3 or greater

- Pregnancy

- Monitored anesthesia using propofol for sedation.

- Vulnerable subjects. Students, nursing home residents, institutionalized patients,
and those with psychological or physical incapacity