Development of Niv Score of Capsule Endoscopy in Patients With Crohn's (CECDAIic)
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|ClinicalTrials.gov Identifier: NCT01793376|
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : July 31, 2019
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|
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Development of Niv Score of Capsule Endoscopy in Patients With Crohn's (CECDAIic)|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||June 2016|
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793376
|Principal Investigator:||Yaron Niv, Prof.||Rabin MC|