Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Georgetown University
Washington D.C. Veterans Affairs Medical Center
University of Washington
Information provided by (Responsible Party):
Artann Laboratories
ClinicalTrials.gov Identifier:
NCT01029899
First received: December 8, 2009
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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
Compare Performance of Colonoscopists

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Artann Laboratories:

Primary Outcome Measures:
  • Colonoscopy Force Monitoring demonstrates patterns of how doctors in training are different from very experienced doctors when they do colonoscopy. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2009
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029899

Locations
United States, District of Columbia
Georgetown University Medical Center, Gastroenterology
Washington, District of Columbia, United States, 20057
Washington DC VA Medical Center
Washington, District of Columbia, United States, 02422
Sponsors and Collaborators
Artann Laboratories
Georgetown University
Washington D.C. Veterans Affairs Medical Center
University of Washington
Investigators
Study Chair: Armen Sarvazyan, Ph.D., D.Sc. Artann Laboratories
  More Information

Publications:
Responsible Party: Artann Laboratories
ClinicalTrials.gov Identifier: NCT01029899     History of Changes
Other Study ID Numbers: CFM-05, 2R44DK068936
Study First Received: December 8, 2009
Last Updated: July 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Artann Laboratories:
Colonoscopy
Force
Monitor
Endoscopist
Trainee

ClinicalTrials.gov processed this record on November 27, 2014