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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Capital Digestive Care, LLC
Mayo Clinic
Sansum Clinic
Georgetown University
Information provided by (Responsible Party):
Artann Laboratories
ClinicalTrials.gov Identifier:
NCT00797914
First received: November 23, 2008
Last updated: March 27, 2014
Last verified: March 2014

November 23, 2008
March 27, 2014
July 2008
January 2015   (final data collection date for primary outcome measure)
CFM can continuously record forces applied to colonoscope by different expert endoscopists during routine outpatient colonoscopy. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00797914 on ClinicalTrials.gov Archive Site
CFM can characterize differences in force patterns for different patients and different endoscopists [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluation of Handheld Colonoscopy Force Monitor by Expert Endoscopists in the Performance of Colonoscopy
Phase I Study for 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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Identify Characteristics of Colonoscopists During Endoscopy
Not Provided
Patients undergoing colonoscopy
Patients who are undergoing outpatient colonoscopy for colorectal cancer screening or for symptoms suggestive of colonic diseases.
Korman LY, Egorov V, Tsuryupa S, Corbin B, Anderson M, Sarvazyan N, Sarvazyan A. Characterization of forces applied by endoscopists during colonoscopy by using a wireless colonoscopy force monitor. Gastrointest Endosc. 2010 Feb;71(2):327-34. Epub 2009 Nov 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
150
January 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00797914
CFM-01, 5R44DK068936
No
Artann Laboratories
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
Artann Laboratories
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP