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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
History of Changes
  Purpose

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 Intervention
Ulcerative Colitis
 Device: PillCam Colon Capsule
Procedure: Standard Colonoscopy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Colon Capsule Endoscopy Versus Standard Colonoscopy in Assessing Disease Activity in Patients With Ulcerative Colitis - A Prospective Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 14
Study Start Date: January 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
UC
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with known ulcerative colitis

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837304

Locations
Germany
University of Muenster, Dept. of Medicine B
Muenster, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
Investigators
Principal Investigator: Tobias Meister, MD University of Muenster, Dept. of Medicine B
  More Information

No publications provided

Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT00837304     History of Changes
Other Study ID Numbers: Med-B_CCE_vs_SC
Study First Received: February 4, 2009
Last Updated: December 7, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 13, 2013