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Completed

NCT Number: NCT00797914

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

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.

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sansum Clinic, Santa Barbara, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. CFM can continuously record forces applied to colonoscope by different expert endoscopists during routine outpatient colonoscopy.

    Time frame: 1 year

Secondary outcomes

  1. CFM can characterize differences in force patterns for different patients and different endoscopists

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Artann Laboratories

Industry

Collaborators

  • Capital Digestive Care, LLC
  • Georgetown University
  • Mayo Clinic
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)
  • Sansum Clinic

Registry information

Official study title

Phase I Study for Evaluation of Handheld Colonoscopy Force Monitor by Expert Endoscopists in the Performance of Colonoscopy

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Nov 25, 2008
Registry last updated
Jul 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.