Experimental Device to Improve Colonoscopy

NCT00719641 | Completed

• 2 other identifiers: 08017308-DK-0173
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Colonoscopy; Looping; Prevent Looping; Colon Cancer Screening

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Cecal Intubation Time

  Cecal intubation time of colonoscopy with SSW, compared to without SSW

  During colonoscopy, up to 60 minutes

• Number of Participants Without Re-looping Among Those With Looping

  Re-looping during the procedure that used SSW, this information only collected when using SSW

  During the colonoscopy, up to 60 minutes

Study Arms (4)

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.

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Meissner HI, Breen N, Klabunde CN, Vernon SW. Patterns of colorectal cancer screening uptake among men and women in the United States. Cancer Epidemiol Biomarkers Prev. 2006 Feb;15(2):389-94. doi: 10.1158/1055-9965.EPI-05-0678.

  PMID: 16492934 BACKGROUND

• Kahi CJ, Rex DK. Current and future trends in colorectal cancer screening. Cancer Metastasis Rev. 2004 Jan-Jun;23(1-2):137-44. doi: 10.1023/a:1025871231346.

  PMID: 15000154 BACKGROUND

• Wu GH, Wang YM, Yen AM, Wong JM, Lai HC, Warwick J, Chen TH. Cost-effectiveness analysis of colorectal cancer screening with stool DNA testing in intermediate-incidence countries. BMC Cancer. 2006 May 24;6:136. doi: 10.1186/1471-2407-6-136.

  PMID: 16723013 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Stephen A Wank, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2008
• First Posted: July 22, 2008
• Study Start: August 5, 2008
• Primary Completion: September 21, 2016
• Study Completion: September 21, 2016
• Last Updated: March 24, 2020

Record last verified: 2019-10

Locations

US (1)