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NCT00719641
Experimental Device to Improve Colonoscopy
trial in Colonoscopy in 42 participants. Completed in 21 September 2016.
21 September 2016
Quick facts
| Lead sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 42 |
| Start date | 5 August 2008 |
| Primary completion | 21 September 2016 |
| Estimated completion | 21 September 2016 |
| Sites | 1 location across United States |
Conditions studied
- Colonoscopy — all drugs for Colonoscopy →
- Looping — all drugs for Looping →
- Prevent Looping — all drugs for Prevent Looping →
- Colon Cancer Screening — all drugs for Colon Cancer Screening →
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Who can join
Adults 40 to 80, any sex, with Colonoscopy or Looping. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00719641
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00719641 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Last refreshed: 24 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00719641.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing