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OpenTrials
Completed

NCT Number: NCT01029899

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

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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Key information

Conditions

Compare Performance of Colonoscopists

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic, Rochester, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Colonoscopy Force Monitoring demonstrates patterns of how doctors in training are different from very experienced doctors when they do colonoscopy.

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Artann Laboratories

Industry

Collaborators

  • Georgetown University
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)
  • University of Washington
  • Washington D.C. Veterans Affairs Medical Center

Registry information

Official study title

Phase II Study of Evaluation of Handheld Colonoscopy Force Monitor by Expert and Trainee Endoscopists in the Performance of Colonoscopy

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Dec 10, 2009
Registry last updated
Jul 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.