Experimental Device to Improve Colonoscopy
Public ClinicalTrials.gov record NCT00719641. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Trial of Segmental Stiffening Wires to Improve the Efficiency and Patient Tolerability of Colonoscopy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00719641
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 42 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 40 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 4, 2008
- Primary completion
- Sep 20, 2016
- Completion
- Sep 20, 2016
- Last update posted
- Mar 23, 2020
2008 – 2016
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00719641, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 23, 2020 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00719641 live on ClinicalTrials.gov.