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

Sponsor
Medtronic - MITG (Industry)
Overall Status
Completed
CT.gov ID
NCT01793376
Collaborator
(none)
30
Enrollment
40
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Development of Niv Score of Capsule Endoscopy in Patients With Crohn's (CECDAIic)
    Study Start Date :
    Feb 1, 2013
    Actual Primary Completion Date :
    Feb 1, 2016
    Actual Study Completion Date :
    Jun 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. The inter-observer variability of the new CD Colonic Score, between four reviewers in Crohn's Disease patients with large bowel involvement [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • videos of colon Crohn's disease subjects who have undergone the Colon 2 CE procedure will be included.
    Exclusion Criteria:

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Medtronic - MITG

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medtronic - MITG
    ClinicalTrials.gov Identifier:
    NCT01793376
    Other Study ID Numbers:
    • MA-208-1
    First Posted:
    Feb 15, 2013
    Last Update Posted:
    Jul 31, 2019
    Last Verified:
    Jul 1, 2019
    Additional relevant MeSH terms:
    Crohn Disease

    Study Results

    No Results Posted as of Jul 31, 2019