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

A

Artann Laboratories

Status

Completed

Conditions

Compare Performance of Colonoscopists

Study type

Observational

Funder types

Other
Industry
Other U.S. Federal agency
NIH

Identifiers

NCT01029899
2R44DK068936 (U.S. NIH Grant/Contract)
CFM-05

Details and patient eligibility

About

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.

Full 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.

Enrollment

153 patients

Sex

All

Ages

30 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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