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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Notify MeKey information
Age range
30 year–75 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Sansum Clinic, Santa Barbara, California, United States
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
-
CFM can continuously record forces applied to colonoscope by different expert endoscopists during routine outpatient colonoscopy.
Time frame: 1 year
Secondary outcomes
-
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.