Colon Capsule Endoscopy Versus Standard Colonoscopy in Ulcerative Colitis

NCT00837304 | Terminated DMC

• 1 other identifier: Med-B_CCE_vs_SC
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• a) disease activity of ulcerative colitis (modified Rachmilewitz score) b) extent of colonic manifestation of ulcerative colitis c) accuracy parameters (sensitivity, specificity)

  12 months

Secondary Outcomes (1)

• 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)

  12 months

Study Arms (1)

UC

Patients with known ulcerative colitis

Device: PillCam Colon Capsule; Procedure: Standard Colonoscopy

Interventions

PillCam Colon Capsule DEVICE

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.

UC

Standard Colonoscopy PROCEDURE

Standard Colonoscopy: Pts. undergo colonoscopy with a video colonoscope (CF H180 AI; Olympus, Tokyo, Japan).

UC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with known ulcerative colitis

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

University of Muenster, Dept. of Medicine B

Münster, 48149, Germany

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Tobias Meister, MD

  University of Muenster, Dept. of Medicine B

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2009
• First Posted: February 5, 2009
• Study Start: January 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: December 10, 2012

Record last verified: 2009-02

Locations

DE (1)