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Colon Capsule Endoscopy Versus Standard Colonoscopy in Ulcerative Colitis

NCT ID: NCT00837304

Last Updated: 2012-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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UC

Patients with known ulcerative colitis

PillCam Colon Capsule

Intervention Type 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.

Standard Colonoscopy

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type DEVICE

Standard Colonoscopy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Muenster

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tobias Meister, MD

Role: PRINCIPAL_INVESTIGATOR

University of Muenster, Dept. of Medicine B

Locations

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University of Muenster, Dept. of Medicine B

Münster, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Med-B_CCE_vs_SC

Identifier Type: -

Identifier Source: org_study_id