Development of Niv Score of Capsule Endoscopy in Patients With Crohn's (CECDAIic)

July 29, 2019 updated by: Medtronic - MITG

Hypothesis This study is designed as an integral part of the development of a new CE score for Crohn's disease.

The SB (small bowel) CD (Crohn's Disease)Niv score (CECDAI) is an established and validated CD score for SB involvement. In order to expand this score to the colon, this study will aim to develop the colonic score and later on will be combined with the already established SB score in order to achieve a full CE gut score for Crohn's disease Proposed Design This is a retrospective study in which up to 30 videos of colon Crohn's disease subjects who have undergone the Colon 2 CE procedure will be evaluated.

These cases will have evidence of large and / or small bowel Crohn's disease The chosen videos will be marked for CD lesions by the site The de-identified marked videos will be scored by 4 independent experienced endoscopists, blinded to the results of the standard workup procedures, according to the colonic and CECDAIic new scores

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

videos of colon Crohn's disease subjects who have undergone the Colon 2 CE procedure will be included.

Description

Inclusion Criteria:

  • videos of colon Crohn's disease subjects who have undergone the Colon 2 CE procedure will be included.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The inter-observer variability of the new CD Colonic Score, between four reviewers in Crohn's Disease patients with large bowel involvement
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic - MITG

Investigators

  • Principal Investigator: Yaron Niv, Prof., Rabin MC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

February 13, 2013

First Submitted That Met QC Criteria

February 14, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Actual)

July 31, 2019

Last Update Submitted That Met QC Criteria

July 29, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA-208-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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