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
  Purpose

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
Identify Characteristics of Colonoscopists During Endoscopy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Artann Laboratories:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • CFM can characterize differences in force patterns for different patients and different endoscopists [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: July 2008
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients undergoing colonoscopy
Patients who are undergoing outpatient colonoscopy for colorectal cancer screening or for symptoms suggestive of colonic diseases.

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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
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.

Criteria

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
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: NCT00797914

Locations
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
Capital Digestive Care, LLC
Mayo Clinic
Sansum Clinic
Georgetown University
Investigators
Principal Investigator: Louis Y Korman, M.D. Capital Digestive Care, LLC
  More Information

Publications:
Responsible Party: Artann Laboratories
ClinicalTrials.gov Identifier: NCT00797914     History of Changes
Other Study ID Numbers: CFM-01, 5R44DK068936
Study First Received: November 23, 2008
Last Updated: March 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Artann Laboratories:
Colonoscopy
Instrumentation
Force Monitoring
Quality Control
Training

ClinicalTrials.gov processed this record on August 27, 2014