Characterize Differences in Force Patterns Used by Different Endoscopists and Trainee Endoscopists
Phase II Study of Evaluation of Handheld Colonoscopy Force Monitor by Expert and Trainee Endoscopists in the Performance of Colonoscopy
2 other identifiers
observational
153
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2009
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 8, 2009
CompletedFirst Posted
Study publicly available on registry
December 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedJuly 12, 2016
July 1, 2016
6.1 years
December 8, 2009
July 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Colonoscopy Force Monitoring demonstrates patterns of how doctors in training are different from very experienced doctors when they do colonoscopy.
18 months
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Artann Laboratorieslead
- National Institutes of Health (NIH)collaborator
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
- Georgetown Universitycollaborator
- Washington D.C. Veterans Affairs Medical Centercollaborator
- University of Washingtoncollaborator
Study Sites (2)
Mayo Clinic
Rochester, Minnesota, 55905, United States
The University of Washington
Seattle, Washington, 98195, United States
Related Publications (1)
Korman LY, Brandt LJ, Metz DC, Haddad NG, Benjamin SB, Lazerow SK, Miller HL, Greenwald DA, Desale S, Patel M, Sarvazyan A. Segmental increases in force application during colonoscope insertion: quantitative analysis using force monitoring technology. Gastrointest Endosc. 2012 Oct;76(4):867-72. doi: 10.1016/j.gie.2012.05.030. Epub 2012 Jul 27.
PMID: 22840291RESULT
Study Officials
- STUDY CHAIR
Armen Sarvazyan, Ph.D., D.Sc.
Artann Laboratories
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2009
First Posted
December 10, 2009
Study Start
December 1, 2009
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
July 12, 2016
Record last verified: 2016-07