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

Completed

Conditions studied: Identify Characteristics of Colonoscopists During Endoscopy

In brief

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.

Key facts

Study ID

NCT00797914

Run by

Artann Laboratories

People needed

150

Starts

2008-07-01

Expected to finish

2016-06-01

Last updated by the study team

2016-07-12

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female
• Age: 30-75 years
• ASA Class I or II
• All ethnic and racial groups will be included

You may not qualify if…

• 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

Where it is running

• Sansum Clinic — Santa Barbara, California, United States
• Chevy Chase Endoscopy Center — Chevy Chase, Maryland, United States
• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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