Cap Assisted Colonoscopy for the Detection of Colon Polyps
|ClinicalTrials.gov Identifier: NCT01211132|
Recruitment Status : Unknown
Verified September 2010 by Kansas City Veteran Affairs Medical Center.
Recruitment status was: Recruiting
First Posted : September 29, 2010
Last Update Posted : September 29, 2010
|Condition or disease||Intervention/treatment|
|Adenoma Colon Polyps Colon Cancer||Device: Cap - Transparent retractable extension device. Device: Standard|
The investigators hypothesize that adenoma detection rate will be higher using cap assisted colonoscopy compared to standard colonoscopy. Also, cap assisted colonoscopy will be safe and cecal intubation rate will be similar compared to standard colonoscopy.
Specific Aim 1 - To compare the prevalence of adenomas detected by standard colonoscopy and cap assisted colonoscopy.
Specific Aim 2 - To compare the number of adenomas detected per subject by standard colonoscopy and cap assisted colonoscopy.
Specific aim 3 - To compare the cecal intubation rate, insertion time, withdrawal time and complications of standard colonoscopy and cap assisted colonoscopy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||462 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prospective Randomized Controlled Study of Cap Assisted Colonoscopy for the Detection of Colon Polyps|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||October 2010|
|Estimated Study Completion Date :||November 2010|
|Active Comparator: Cap arm||
Device: Cap - Transparent retractable extension device.
Attaching a Cap - Transparent retractable extension device.
Other Name: Cap Assisted Colonoscopy
|Active Comparator: Standard arm||
Without attaching a transparent cap to the tip of colonoscope.
Other Name: Standard Colonoscopy
- The primary outcome is the prevalence of adenomas in the two groups. [ Time Frame: 2 years ]
- The secondary outcomes are the number of adenomas detected per subject, cecal intubation rate, insertion times, withdrawal times and complication rates in the two arms. [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01211132
|Contact: Deepthi S Rao, MBBS||816-861-4700 ext 56428||Deepthi.Rao@va.gov|
|United States, Missouri|
|Veterans Affairs Medical Center||Recruiting|
|Kansas City, Missouri, United States, 64128|
|Contact: Deepthi S Rao, MBBS 816-861-4700 ext 56428 Deepthi.Rao@va.gov|
|Principal Investigator:||Amit Rastogi, MD||Veterans Affairs Medical Center, Kansas City, MO|