Experimental Device to Improve Colonoscopy
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|ClinicalTrials.gov Identifier: NCT00719641|
Recruitment Status : Completed
First Posted : July 22, 2008
Last Update Posted : March 24, 2020
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 and removing growths called polyps, which can become colon cancer. Sometimes the flexible tube (colonoscope) used in the procedure loops at a certain point as it advances through the colon, making it difficult to move further and causing the patient pain from excessive stretching of the colon. The SSW is designed to prevent this by stiffening the part of the tube that would otherwise form the loop.
Healthy subjects between 50 and 80 years of age and healthy subjects 40 years and older who have a family history of colon cancer may be eligible for this study.
Participants undergo colonoscopy a day after self-administering a bowel cleansing preparation. The first part of the procedure is done similarly to that of a flexible sigmoidoscopy, and no sedation or pain medication is used. The colonoscope is inserted into the rectum and advanced about one-third the length of the colon. Pain or discomfort should be mild to moderate cramping and a feeling of having to move the bowels. The subject is asked to score his or her pain level at this point using a standard pain scale. If there is pain, the procedure is stopped and an x-ray is taken to determine if the colonoscope has looped. If it has, the loop is undone and the SSW is used. Another x-ray is then taken to document that the loop has been prevented with the SSW, and the procedure is completed as per standard medical practice. Subjects are taken to the recovery area, informed of the test results and then discharged home in the care of an accompanying adult.
|Condition or disease|
|Colonoscopy Looping Prevent Looping Colon Cancer Screening|
|Study Type :||Observational|
|Actual Enrollment :||42 participants|
|Official Title:||A Trial of Segmental Stiffening Wires to Improve the Efficiency and Patient Tolerability of Colonoscopy|
|Actual Study Start Date :||August 5, 2008|
|Actual Primary Completion Date :||September 21, 2016|
|Actual Study Completion Date :||September 21, 2016|
Phase 1: Single Colonoscopy
Feasibility testing using the segmental stiffening wire
Phase 2; Not randomized
Phase 2 participants who did not have looping during first colonoscopy
Phase 2: Randomized to SSW during first colonoscopy
Phase 2 participants in whom looping occurred on first biopsy, randomized to subsequent use of segmental stiffening wire, then colonoscopy with no segmental stiffening wire upon repeat colonoscopy the next day.
Phase 2: Randomized to SSW during second colonoscopy
Phase 2 participants in whom looping occurred on first biopsy, randomized to no subsequent use of the segmental stiffening wire that day, then colonoscopy with segmental stiffening wire upon repeat colonoscopy the next day.
- Cecal Intubation Time [ Time Frame: During colonoscopy, up to 60 minutes ]Cecal intubation time of colonoscopy with SSW, compared to without SSW
- Number of Participants Without Re-looping Among Those With Looping [ Time Frame: During the colonoscopy, up to 60 minutes ]Re-looping during the procedure that used SSW, this information only collected when using SSW
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719641
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Stephen A Wank, M.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|