Colon Capsule Endoscopy Versus Standard Colonoscopy in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

Colon Capsule Endoscopy Versus Standard Colonoscopy in Assessing Disease Activity in Patients With Ulcerative Colitis - A Prospective Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00837304
• Other study ID #: Med-B_CCE_vs_SC
• Status: Terminated
• Phase: N/A
• First received: February 4, 2009
• Last updated: December 7, 2012
• Start date: January 2009
• Est. completion date: July 2012

Study information

• Verified date: February 2009
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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).

Locations

Country	Name	City	State
Germany	University of Muenster, Dept. of Medicine B	Muenster

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a) disease activity of ulcerative colitis (modified Rachmilewitz score) b) extent of colonic manifestation of ulcerative colitis c) accuracy parameters (sensitivity, specificity)		12 months	Yes
Secondary	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	Yes