Colon Capsule Endoscopy Versus Standard Colonoscopy in Ulcerative Colitis
|ClinicalTrials.gov Identifier: NCT00837304|
Recruitment Status : Terminated
First Posted : February 5, 2009
Last Update Posted : December 10, 2012
The dimension of diagnostic procedures and therapy of chronic inflammatory bowel diseases largely depends on the degree of mucosal inflammation. Video colonoscopy is currently the gold standard in the evaluation of the mucosa in patients with Ulcerative Colitis (UC). PillCam Colon Capsule was developed by Given Imaging, Israel, as possible alternative imaging modality to evaluate mucosal changes in patients with UC. The colonic mucosa can be visualized and recorded by video while the colon capsule passes the colon.
Many patients suffering from UC ask their physician for possible alternative diagnostic imaging because they are uncomfortable with conventional colonoscopy.
The primary aim of the present study is to compare the new Pillcam Colon Capsule with standard colonoscopy with respect to assessing mucosal disease activity and localization of inflamed colonic mucosa in patients with known UC.
|Condition or disease||Intervention/treatment|
|Ulcerative Colitis||Device: PillCam Colon Capsule Procedure: Standard Colonoscopy|
|Study Type :||Observational|
|Actual Enrollment :||14 participants|
|Observational Model:||Case Control|
|Official Title:||Colon Capsule Endoscopy Versus Standard Colonoscopy in Assessing Disease Activity in Patients With Ulcerative Colitis - A Prospective Trial|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
Patients with known ulcerative colitis
Device: PillCam Colon Capsule
PillCam Colon Capsule: The PillCam Colon capsule has two cameras that enable the device to take video images from both ends. It is 31.11 mm in size and takes pictures at a rate of 4 frames per second. The delay mode allows recording of images from the esophagus and the stomach for 5 minutes before the capsule switches into sleep mode for 2 hours to save energy.Procedure: Standard Colonoscopy
Standard Colonoscopy: Pts. undergo colonoscopy with a video colonoscope (CF H180 AI; Olympus, Tokyo, Japan).
- a) disease activity of ulcerative colitis (modified Rachmilewitz score) b) extent of colonic manifestation of ulcerative colitis c) accuracy parameters (sensitivity, specificity) [ Time Frame: 12 months ]
- a) patient comfort b) detection of polyps c) differences in recognition of disease activity (physicians, nurses) d) differences in findings in the group of physicians (inter-observer differences) [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00837304
|University of Muenster, Dept. of Medicine B|
|Muenster, Germany, 48149|
|Principal Investigator:||Tobias Meister, MD||University of Muenster, Dept. of Medicine B|