Characterize Differences in Force Patterns Used by Different Endoscopists and Trainee Endoscopists

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2016-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Compare Performance of Colonoscopists

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes