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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01793376
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

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
Crohn's Disease

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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 : February 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : June 2016

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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 [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
videos of colon Crohn's disease subjects who have undergone the Colon 2 CE procedure will be included.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

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


Sponsors and Collaborators
Medtronic - MITG
Investigators
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Principal Investigator: Yaron Niv, Prof. Rabin MC

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Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01793376    
Other Study ID Numbers: MA-208-1
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases