Clinical trial NCT01029899: Characterize Differences in Force Patterns Used by Different Endoscopists and Trainee Endoscopists
Official title: Phase II Study of Evaluation of Handheld Colonoscopy Force Monitor by Expert and Trainee Endoscopists in the Performance of Colonoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Compare Performance of Colonoscopists
Keywords: Colonoscopy
Force
Monitor
Endoscopist
Trainee
Lead sponsor: Artann Laboratories
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Georgetown University
name: Washington D.C. Veterans Affairs Medical Center
name: University of Washington
First posted: 2009-12-10
Enrollment: 153
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Colonoscopy Force Monitoring demonstrates patterns of how doctors in training are different from very experienced doctors when they do colonoscopy.
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Seattle
country: United States
facility: The University of Washington
state: Washington
Study officials:
affiliation: Artann Laboratories
name: Armen Sarvazyan, Ph.D., D.Sc.
role: STUDY_CHAIR
References:
citation: 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.