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Evaluation of Handheld Colonoscopy Force Monitor by Expert Endoscopists in the Performance of Colonoscopy

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ClinicalTrials.gov Identifier: NCT00797914
Recruitment Status : Completed
First Posted : November 25, 2008
Last Update Posted : July 12, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate a handheld Colonoscopy Force Monitor(CFM™), a push-pull force and torque measuring device, that grips the shaft of the colonoscope and wirelessly transmits and records all the forces applied by the endoscopist during colonoscopy.

Condition or disease
Identify Characteristics of Colonoscopists During Endoscopy

Detailed Description:
Colonoscopy requires a skilled endoscopist to use visual and tactile information to advance and withdraw the instrument through a series of fixed and stationary loops. To develop and maintain the skills necessary to perform colonoscopy safely and effectively requires extensive training and ongoing education. Quantification of tactile information provides the opportunity to understand the "feel" used by the endoscopist to perform colonoscopy. The identification of force application patterns has the potential to enhance training and improve performance. CFM™ is a handheld device that uses load cells to transform applied force to electric signals and to transmit wirelessly the signal to a computer for storage and visual display. The device is designed so that the endoscopist maintains a conventional hand position and uses an electronically controlled grip and release mechanism to fix the position on the instrument. Several expert endoscopists from multiple institutions will use the CFM™ to perform colonoscopy. The data will be recorded and analyzed for differences by patient characteristics(e.g. gender, age, pain sensation, surgical history) and by endoscopist.

Study Design

Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Phase I Study for Evaluation of Handheld Colonoscopy Force Monitor by Expert Endoscopists in the Performance of Colonoscopy
Study Start Date : July 2008
Primary Completion Date : June 2016
Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Groups and Cohorts

Patients undergoing colonoscopy
Patients who are undergoing outpatient colonoscopy for colorectal cancer screening or for symptoms suggestive of colonic diseases.

Outcome Measures

Primary Outcome Measures :
  1. CFM can continuously record forces applied to colonoscope by different expert endoscopists during routine outpatient colonoscopy. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. CFM can characterize differences in force patterns for different patients and different endoscopists [ Time Frame: 2 years ]

Eligibility Criteria

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:   No
Sampling Method:   Non-Probability Sample
Study Population
All adult male and female patients between the ages of 30 and 75 presenting to the Chevy Chase Endoscopy Center for screening or diagnostic colonoscopy to be performed by any of the investigators will be considered for inclusion.

Inclusion Criteria:

  • Male or female
  • Age: 30-75 years
  • ASA Class I or II
  • All ethnic and racial groups will be included

Exclusion Criteria:

  • Colonic 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
  • Monitored anesthesia using propofol for sedation.
  • Vulnerable subjects. Students, nursing home residents, institutionalized patients, and those with psychological or physical incapacity
Contacts and Locations

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): NCT00797914

United States, California
Sansum Clinic
Santa Barbara, California, United States, 93105
United States, Maryland
Chevy Chase Endoscopy Center
Chevy Chase, Maryland, United States, 20815
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Artann Laboratories
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Capital Digestive Care, LLC
Mayo Clinic
Sansum Clinic
Georgetown University
Principal Investigator: Louis Y Korman, M.D. Capital Digestive Care, LLC
More Information

Responsible Party: Artann Laboratories
ClinicalTrials.gov Identifier: NCT00797914     History of Changes
Other Study ID Numbers: CFM-01
5R44DK068936 ( U.S. NIH Grant/Contract )
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016

Keywords provided by Artann Laboratories:
Force Monitoring
Quality Control