Characterize Differences in Force Patterns Used by Different Endoscopists and Trainee Endoscopists
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ClinicalTrials.gov Identifier: NCT01029899
Recruitment Status :
First Posted : December 10, 2009
Last Update Posted : July 12, 2016
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The study is to evaluate how doctors in training are different from very experienced doctors when using force to perform colonoscopy with a device that monitors the amount of force applied to the colonoscope during colonoscopy.
Condition or disease
Compare Performance of Colonoscopists
The study consists of two sequential observational studies designed to identify which instrument should be used to assess trainee performance and to quantify trainee skill development in performance of colonoscopy over the course of their training program.
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Ages Eligible for Study:
30 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
All adult male and female patients between the ages of 30 and 75 presenting for screening or diagnostic colonoscopy to be performed by any of the investigators.
Patients undergoing diagnostic or screening colonoscopy ASA Class I or II
All ethnic and racial groups will be included
Able to comprehend, sign and date the written informed consent form (ICF)
English is their primary language
Chronic 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
Vulnerable subjects. Students, nursing home residents, institutionalized patients, and those with psychological or physical incapacity