Status:
COMPLETED
Evaluation of Handheld Colonoscopy Force Monitor by Expert Endoscopists in the Performance of Colonoscopy
Lead Sponsor:
Artann Laboratories
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Identify Characteristics of Colonoscopists During Endoscopy
Eligibility:
All Genders
30-75 years
Brief Summary
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...
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 skil...
Eligibility Criteria
Inclusion
- Male or female
- Age: 30-75 years
- ASA Class I or II
- All ethnic and racial groups will be included
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00797914
Start Date
July 1 2008
End Date
June 1 2016
Last Update
July 12 2016
Active Locations (3)
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1
Sansum Clinic
Santa Barbara, California, United States, 93105
2
Chevy Chase Endoscopy Center
Chevy Chase, Maryland, United States, 20815
3
Mayo Clinic
Rochester, Minnesota, United States, 55905