Status:
COMPLETED
Experimental Device to Improve Colonoscopy
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Colonoscopy
Looping
Eligibility:
All Genders
40-80 years
Brief Summary
This study will test the use of a new device called a segmental stiffening wire (SSW) in colonoscopy to correct a problem called looping. Colonoscopy is the best test for detecting early colon cancer ...
Detailed Description
Colonoscopy can be challenging to perform and painful due to looping of the colonoscope. Looping occurs when further insertion of the colonoscope results in a loop forming in the shaft of the colonosc...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Colonoscopy is indicated based on well-established national guidelines. This includes volunteers age 50 or greater who are at average risk for colon cancer, and volunteers age 40 or greater who are at increased risk based on a personal history of colon polyps or a family history of colon polyps or cancer.
- Volunteer meets the criteria of Anesthesia Level 1 or 2.
- Volunteer agrees to undergo the study procedures.
- EXCLUSION CRITERIA:
- Ongoing psychiatric history including volunteers who have been hospitalized for psychiatric reasons, have missed significant number of days of work for psychiatric reasons, or who admit to suicidal ideations.
- Former or current history of alcohol or drug dependency.
- History of colonic resection.
- Pregnancy.
- Age greater than 80 or less than 40.
- Prior radiation to the abdomen or pelvis.
- American Society of Anesthesiologists Grade 3, 4, or 5.
- Allergy or other contraindications to midazolam or fentanyl.
Exclusion
Key Trial Info
Start Date :
August 5 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 21 2016
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00719641
Start Date
August 5 2008
End Date
September 21 2016
Last Update
March 24 2020
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892