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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01029899
Enrollment
153
Registered
2009-12-10
Start date
2009-12-31
Completion date
2016-01-31
Last updated
2016-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compare Performance of Colonoscopists

Keywords

Colonoscopy, Force, Monitor, Endoscopist, Trainee

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.

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.

Interventions

None listed

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Georgetown University
CollaboratorOTHER
Washington D.C. Veterans Affairs Medical Center
CollaboratorFED
University of Washington
CollaboratorOTHER
Artann Laboratories
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Colonoscopy Force Monitoring demonstrates patterns of how doctors in training are different from very experienced doctors when they do colonoscopy.18 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026