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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01793376
Other study ID # MA-208-1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2013
Est. completion date June 2016

Study information

Verified date July 2019
Source Medtronic - MITG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

-

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Medtronic - MITG

Outcome

Type Measure Description Time frame Safety issue
Primary The inter-observer variability of the new CD Colonic Score, between four reviewers in Crohn's Disease patients with large bowel involvement 1 year
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