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

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ClinicalTrials.gov Identifier: NCT01029899
Recruitment Status : Completed
First Posted : December 10, 2009
Last Update Posted : July 12, 2016
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Georgetown University
Washington D.C. Veterans Affairs Medical Center
University of Washington
Information provided by (Responsible Party):
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.

Condition or disease
Compare Performance of Colonoscopists

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.

Study Type : Observational
Actual Enrollment : 153 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Phase II Study of Evaluation of Handheld Colonoscopy Force Monitor by Expert and Trainee Endoscopists in the Performance of Colonoscopy
Study Start Date : December 2009
Primary Completion Date : January 2016
Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029899


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Washington
The University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Artann Laboratories
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Georgetown University
Washington D.C. Veterans Affairs Medical Center
University of Washington
Investigators
Study Chair: Armen Sarvazyan, Ph.D., D.Sc. Artann Laboratories