This trial is active, not recruiting.

Condition crohn's disease
Sponsor Given Imaging Ltd.
Start date February 2013
End date February 2016
Trial size 30 participants
Trial identifier NCT01793376, MA-208-1


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Time perspective retrospective

Primary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Development of Niv Score of Capsule Endoscopy in Patients With Crohn's (CECDAIic)
Principal investigator Yaron Niv, Prof.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Given Imaging Ltd..