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Protocol Details

A Trial of Segmental Stiffening Wires to Improve the Efficiency and Patient Tolerability of Colonoscopy

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

08-DK-0173

Sponsoring Institute

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 40
Max Age: 80

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Colonoscopy;
Looping;
Prevent Looping;
Colon Cancer Screening;
Segmental Stiffening Wire

Recruitment Keyword(s)

None

Condition(s)

Colonoscopy;
Looping;
Prevent Looping;
Colon Cancer Screening

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

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.

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Eligibility

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Stephen A. Wank, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 10 RM 9C101
10 CENTER DR
BETHESDA MD 20814
(301) 496-4202
stevew@mail.nih.gov

Stephen A. Wank, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 10 RM 9C101
10 CENTER DR
BETHESDA MD 20814
(301) 496-4202
stevew@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT00719641

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