Capsule Endoscopy Crohn's Disease Activity Index - Validation Multi Center Study - Full Text View

Sponsors and Collaborators:	Rabin Medical Center Department of Veterans Affairs Evangelisches Krankenhaus Kalk. Koln Rambam Health Care Campus Assaf-Harofeh Medical Center Hillel Yaffe Medical Center University of Athens GI Center, Dublin
Information provided by:	Rabin Medical Center
ClinicalTrials.gov Identifier:	NCT00596700

Purpose

The Study

Prospective trial of the Niv score validating score against known activity indices - see addendum A for Niv score
Known Crohn's disease patients undergoing capsule endoscopy are identified - see addendum B for inclusion/exclusion criteria
Prior to capsule exam, temperature is taken, height and weight measured, bloods are drawn for albumin, ESR, HCT, CRP
Prior to capsule exam, symptom/exam questionnaire is completed - see addendum C for questionnaire
Capsule exam is performed
CD of de-identified is made at the study site.
Landmarks are confirmed and the small bowel transit time is divided into 2 and labeled on thumbnails
CDs are copied
CDs of study patients are provided to blinded readers

Condition	Intervention
Crohn's Disease	Device: Capsule endoscopy

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease Endoscopy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Capsule Endoscopy Crohn's Disease Activity Index - Validation Multi Center Study

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:

This prospective study is aimed to evaluate the correlation of capsule endoscopy CECDAI with the CDAI (accepted clinical index) and IBDQ (quality of life questionnaire) in patients suffering from small-bowel Crohn's disease

Secondary Outcome Measures:

Capsule endoscopy investigation and crohn's disease outcome

Estimated Enrollment:	100
Study Start Date:	January 2007
Estimated Study Completion Date:	June 2008

Detailed Description:

The Niv score was devised to measure mucosal disease activity in Crohn's disease using capsule endoscopy. This scoring index is based on inflammatory score parameters: Erythema, hyperemia, edema, denudation, nodularity, apthae, erosion, ulcer, bleeding), extent score: Focal, patchy, diffuse, and stricture score: single-passed, multiple-passed, obstruction. The higher the score, the more involvement is observed. The advantage of this index is that it actually measures disease activity and not symptoms in an easy non-invasive manner. For assessing Crohn's disease, mucosal healing can be directly seen and if there is no mucosal disease there can be no symptoms secondary to inflammatory bowel disease. The subjective nature of disease activity indices is avoided, as is the problem of disease without symptoms. It is envisioned that the Niv score could diagnose Crohn's disease (excluding normally occurring mucosal breaks), identify NSAID damage, measure disease activity / severity, measure drug response for clinical trials and in practice, and guide medical management for the patient's with small bowel Crohn's disease.

This study will measure the Niv score against CDAI. Since capsule endoscopy assesses mucosal disease and not symptoms it is not envisioned that the Niv score will perfectly correlate with the Harvey-Bradshaw score. It is envisioned that the Niv score will have the same direction. Both of these indices will be determined as part of a multicenter trial. The trial design is outlined below.

The Study

Prospective trial of the Niv score validating score against known activity indices - see addendum A for Niv score
Known Crohn's disease patients undergoing capsule endoscopy are identified - see addendum B for inclusion/exclusion criteria
Prior to capsule exam, temperature is taken, height and weight measured, bloods are drawn for albumin, ESR, HCT, CRP
Prior to capsule exam, symptom/exam questionnaire is completed - see addendum C for questionnaire
Capsule exam is performed
CD of de-identified is made at the study site.
Landmarks are confirmed and the small bowel transit time is divided into 2 and labeled on thumbnails
CDs are copied
CDs of study patients are provided to blinded readers

Scoring sheets will be provided to readers - see addendum A
Readers will score the CDs and return the scoring sheets to the principal investigator
Data is collated and analyzed

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients 18 years or older and not greater than 80 years suffer from Crohn's Disease of the small bowel, documented by clinical, endoscopical, histopathological and radiological parameters, in any activity stage iof the disease and any treatment
Documented written Informed Consent

Exclusion Criteria:

Subject suffers from swallowing difficulties
Female subject is pregnant or nursing (in case of necessary small bowel series a pregnancy test has to be performed prior to the test)
Subject is known to suffer from intestinal obstruction
Subject has a cardiac pacemakers or other implanted electro medical devices
Patients with more than 40% small bowel resect
Subject has any condition, which precludes compliance with study and/or device instructions
Subject suffers from life threatening conditions
Subject is currently participating in another clinical study
Subject with colonic involvement of Crohn's disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596700

Contacts

Contact: Yaron Niv, MD, AGAF, FACG	972-3-9377237	yniv@clalit.org.il
Contact: Tami Lederfein, BSc	972-3-9277237	yniv@clalit.org.il

Locations

Israel
Rabin Medical Center, Beilinson Hospital, Tel Aviv University
Petach Tikva, Israel, 49100

Sponsors and Collaborators

Rabin Medical Center

Department of Veterans Affairs

Evangelisches Krankenhaus Kalk. Koln

Rambam Health Care Campus

Assaf-Harofeh Medical Center

Hillel Yaffe Medical Center

University of Athens

GI Center, Dublin

Investigators

Principal Investigator:

Yaron Niv, MD, AGAF, FACG

RMC, Tel Aviv University

More Information

Study ID Numbers:	CECDAI-2006
Study First Received:	January 8, 2008
Last Updated:	January 16, 2008
ClinicalTrials.gov Identifier:	NCT00596700
Health Authority:	Israel: Ministry of Health

Keywords provided by Rabin Medical Center:

Capsule endoscopy
Crohn's disease
IBD

Activity score
Small bowel
Crohn's disease of the small bowel in any stage

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Crohn Disease

Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases

ClinicalTrials.gov processed this record on January 16, 2009