Colon Cancer Clinical Trial

Effect of Anesthesia on Force Application During Colonoscopy

Summary

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.

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Full Description

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Colon Cancer

Estimated Enrollment:

102

Study ID:

NCT02101099

Recruitment Status:

Completed

Sponsor:

Artann Laboratories

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There are 3 Locations for this study

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Georgetown University Medical Center, Gastroenterology
Washington District of Columbia, 20057, United States
Chevy Chase Endoscopy Center
Chevy Chase Maryland, 20815, United States
Univeristy of Pennsylvania Medical Center
Philadelphia Pennsylvania, 19104, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Estimated Enrollment:

102

Study ID:

NCT02101099

Recruitment Status:

Completed

Sponsor:


Artann Laboratories

How clear is this clinincal trial information?

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