Effect of Cap-Fitted Colonoscopy on Miss Rates at Colonoscopy

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00577083
• Date of registration: 11/12/2007
• Primary sponsor: Indiana University
• Public title: Effect of Cap-Fitted Colonoscopy on Miss Rates at Colonoscopy
• Scientific title: Effect of Cap-Fitted Colonoscopy on Miss Rates at Colonoscopy
• Date of first enrolment: November 2006
• Target sample size: 106
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00577083
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Screening

Countries of recruitment

United States

Contacts

• Name: Douglas K Rex, MD
• Affiliation: Indiana University School of Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

- 50 years of age or older, undergoing scheduled colonoscopy and able to give informed
consent.

Exclusion Criteria:

- Previous surgical resection of the colon or rectum

- ASA class III or higher

- Inflammatory bowel disease

- Current use of anticoagulants.



Age minimum: 50 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Polyps

Intervention(s)

Device: Cap-fitted colonoscopy

Primary Outcome(s)

The number of polyps found during the first colonoscopy will be compared to the number of polyps found during the second colonoscopy to determine the miss rate. [Time Frame: after the second colonoscopy is completed]

Secondary Outcome(s)

The time required to remove and retrieve polyps with and without the cap on will be measured using a stopwatch as a secondary end point. [Time Frame: after both colonoscopies are completed]

Secondary ID(s)

0501-30

Source(s) of Monetary Support

Please refer to primary and secondary sponsors