Evaluation of Handheld Colonoscopy Force Monitor by Expert Endoscopists in the Performance of Colonoscopy
The purpose of this study is to evaluate a handheld Colonoscopy Force Monitor(CFM™), a push-pull force and torque measuring device, that grips the shaft of the colonoscope and wirelessly transmits and records all the forces applied by the endoscopist during colonoscopy.
Identify Characteristics of Colonoscopists During Endoscopy
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Phase I Study for Evaluation of Handheld Colonoscopy Force Monitor by Expert Endoscopists in the Performance of Colonoscopy|
- CFM can continuously record forces applied to colonoscope by different expert endoscopists during routine outpatient colonoscopy. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- CFM can characterize differences in force patterns for different patients and different endoscopists [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2008|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Patients undergoing colonoscopy
Patients who are undergoing outpatient colonoscopy for colorectal cancer screening or for symptoms suggestive of colonic diseases.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00797914
|United States, California|
|Santa Barbara, California, United States, 93105|
|United States, Maryland|
|Chevy Chase Endoscopy Center|
|Chevy Chase, Maryland, United States, 20815|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Louis Y Korman, M.D.||Capital Digestive Care, LLC|