CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Cap-fitted colonoscopydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00577083
NCT00577083N/ACompleted

Cap-fitted Colonoscopy: a Randomized, Tandem Colonoscopy Study of Adenoma Miss Rates

Indiana University·interventional·Posted Dec 19, 2007·Updated Dec 10, 2018

In Brief

A clinical study evaluating Cap-fitted colonoscopy for Polyps. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolyps
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 19, 2007
Enrollment StartNov 1, 2006
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 18.5 years ago

Interventions

Cap-fitted colonoscopydevice

Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination.