Colon Capsule Endoscopy Versus Standard Colonoscopy in Ulcerative Colitis

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00837304
First received: February 4, 2009
Last updated: December 7, 2012
Last verified: February 2009

February 4, 2009
December 7, 2012
January 2009
July 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00837304 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Colon Capsule Endoscopy Versus Standard Colonoscopy in Ulcerative Colitis
Colon Capsule Endoscopy Versus Standard Colonoscopy in Assessing Disease Activity in Patients With Ulcerative Colitis - A Prospective Trial

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with known ulcerative colitis

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).
UC
Patients with known ulcerative colitis
Interventions:
  • Device: PillCam Colon Capsule
  • Procedure: Standard Colonoscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
14
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients over 18 years of age with
  • known ulcerative colitis
  • Indication for Standard Colonoscopy
  • Informed Consent given by the patient

Exclusion Criteria:

  • Patient has dysphagia
  • Patient has congestive heart failure
  • Patient has renal insufficiency
  • Patient is known or is suspected to suffer from intestinal obstruction
  • Patient has a cardiac pacemaker or other implanted electronical medical devices
  • Patient is pregnant
  • Patient has had prior abdominal surgery of the GI tract
  • Patient has any condition, which precludes compliance with study and/or device instructions.
  • Age less than 18
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00837304
Med-B_CCE_vs_SC
Yes
University Hospital Muenster
University Hospital Muenster
Not Provided
Principal Investigator: Tobias Meister, MD University of Muenster, Dept. of Medicine B
University Hospital Muenster
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP