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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01793376

Enrollment

Registered

2013-02-15

Start date

2013-02-28

Completion date

2016-06-30

Last updated

2019-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

Design outcomes

Primary

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	1 year

Outcome results