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

NCT01793376 | Completed

• 1 other identifier: MA-208-1
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• The inter-observer variability of the new CD Colonic Score, between four reviewers in Crohn's Disease patients with large bowel involvement

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Medtronic - MITG: lead

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Yaron Niv, Prof.

  Rabin MC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2013
• First Posted: February 15, 2013
• Study Start: February 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 31, 2019

Record last verified: 2019-07