Characterize Differences in Force Patterns Used by Different Endoscopists and Trainee Endoscopists
Completed
- Conditions
- Compare Performance of Colonoscopists
- Registration Number
- NCT01029899
- Lead Sponsor
- Artann Laboratories
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- Pregnancy
- Vulnerable subjects. Students, nursing home residents, institutionalized patients, and those with psychological or physical incapacity
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Colonoscopy Force Monitoring demonstrates patterns of how doctors in training are different from very experienced doctors when they do colonoscopy. 18 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
The University of Washington
🇺🇸Seattle, Washington, United States