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NCT00577083 · ClinicalTrials.gov registry record · NA
Cap-fitted Colonoscopy: a Randomized, Tandem Colonoscopy Study of Adenoma Miss Rates
A NA study of Polyps, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT00577083: Completed NA study of Polyps, sponsored by Indiana University.
NCT00577083 is a NA study of Polyps that has completed, run by Indiana University. The registered enrollment target is 100 participants, below the 1,092-participant average among 3 other Polyps trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00577083, a NA study of Polyps, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a test in which a thin, black, flexible tube with a lighting system on the end is passed through the anus, into the rectum, in order to examine the large bowel or intestine, also called the colon. Colonoscopy is a very good test for examining the colon for polyps (warty growths that can turn into cancer), but it is not perfect. In fact, about 30% of polyps that are under 5 mm (about 1/5 of an inch) in size are missed during colonoscopy because they are hiding behind folds and bends in the colon. This research study is being done to determine if performing colonoscopy with a cap on the tip of the colonoscope will reduce the miss rate for polyps. A cap is a clear plastic hood that fits on the tip of the colonoscope and sticks out about 1/3 of an inch. During colonoscopy, the cap can be pressed against a fold or ridge in order to flatten it, so that the lining on the other side can be more easily seen. This may reduce the miss rate for colon polyps.
Primary Outcome
Cap Fitted Colonoscopy (CFC) may significantly reduced miss rates for colorectal adenomas, specifically for small adenomas. This study is the first North American study of any design and the largest tandem study of CFC. CFC is a safe, simple, and inexpensive technology that could improve the reliability of colonoscopy in detecting colorectal neoplasia. Additional study of CFC in Western populations is warranted.
Conditions Studied
Interventions
- DEVICE Cap-fitted colonoscopy
Study Locations (1)
Indiana
- Indiana University Medical Center - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2006-11 |
| Est. Completion | 2009-10 |
| Phase | NA |
What the finished NCT00577083 record still lists
NCT00577083 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,092-participant average among 3 other Polyps trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Polyps appearing as the primary indexed condition, and to 1 intervention - of which Cap-fitted colonoscopy is the first listed.
NCT00577083 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT00577083 about?
NCT00577083 is a clinical study titled "Cap-fitted Colonoscopy: a Randomized, Tandem Colonoscopy Study of Adenoma Miss Rates". This is a test in which a thin, black, flexible tube with a lighting system on the end is passed through the anus, into the rectum, in order to examine the large bowel or intestine, also called the colon. Colonoscopy is a very good test for examining the colon for polyps (warty growths that can turn...
What is the current status of trial NCT00577083?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2006-11. Estimated completion is 2009-10.
What conditions does trial NCT00577083 study?
This clinical trial studies the following conditions: Polyps.
What interventions are being tested in trial NCT00577083?
The interventions under investigation include: Cap-fitted colonoscopy (DEVICE).
Who is sponsoring clinical trial NCT00577083?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00577083 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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