Colonoscopy Force Monitor
DeviceUse of Colonoscopy Force Monitoring device (CFM) to measure forces applied to the colonoscope during the procedure.
Other names: CFM
Completed
NCT Number: NCT02101099
Effect of Anesthesia on Force Application During Colonoscopy
The aim of the study is to determine if more force is used during colonoscopy when patients receive monitored anesthesia with propofol versus conscious sedation. Force measurements will be performed using the colonoscopy force monitor (CFM). This device measures the magnitude and direction of force applied to the insertion tube of a standard colonoscope during colonoscopy.
Completed
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Notify MeKey information
Age range
30 year–75 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Georgetown University Medical Center, Gastroenterology, Washington D.C., District of Columbia, United States
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About this study
Randomized factorial design of colonoscopy with either propofol administered anesthesia or conscious sedation. Twelve experienced endoscopists from community and academic centers will perform colonoscopy using either propofol or conscious sedation on a group of 12 patients for each endoscopist for a study total of 144 patients. An equal number of male and female patients will be included in each group.
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
-
Peak push force is increased in patients receiving propofol as compared to conscious sedation.
Time frame: 6 months
Sponsors and collaborators
Lead sponsor
Artann Laboratories
Industry
Collaborators
- Capital Digestive Care, LLC
- Georgetown University
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- University of Pennsylvania
Registry information
Acronym: CFM
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Apr 1, 2014
- 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.