MedTrace Logo

Experimental Device to Improve Colonoscopy

NCT00719641 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2020-03-24

No results posted yet for this study

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

Sponsors & Collaborators

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

    lead NIH

Principal Investigators

  • Stephen A Wank, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-05
Primary Completion
2016-09-21
Completion
2016-09-21

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00719641 on ClinicalTrials.gov