Capsule Endoscopy Crohn's Disease Activity Index - Validation Multi Center Study
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The Study

        1. Prospective trial of the Niv score validating score against known activity indices - see
           addendum A for Niv score

        2. Known Crohn's disease patients undergoing capsule endoscopy are identified - see
           addendum B for inclusion/exclusion criteria

        3. Prior to capsule exam, temperature is taken, height and weight measured, bloods are
           drawn for albumin, ESR, HCT, CRP

        4. Prior to capsule exam, symptom/exam questionnaire is completed - see addendum C for
           questionnaire

        5. Capsule exam is performed

        6. CD of de-identified is made at the study site.

        7. Landmarks are confirmed and the small bowel transit time is divided into 2 and labeled
           on thumbnails

        8. CDs are copied

        9. CDs of study patients are provided to blinded readers
    

Detailed description: 
      The Niv score was devised to measure mucosal disease activity in Crohn's disease using
      capsule endoscopy. This scoring index is based on inflammatory score parameters: Erythema,
      hyperemia, edema, denudation, nodularity, apthae, erosion, ulcer, bleeding), extent score:
      Focal, patchy, diffuse, and stricture score: single-passed, multiple-passed, obstruction. The
      higher the score, the more involvement is observed. The advantage of this index is that it
      actually measures disease activity and not symptoms in an easy non-invasive manner. For
      assessing Crohn's disease, mucosal healing can be directly seen and if there is no mucosal
      disease there can be no symptoms secondary to inflammatory bowel disease. The subjective
      nature of disease activity indices is avoided, as is the problem of disease without symptoms.
      It is envisioned that the Niv score could diagnose Crohn's disease (excluding normally
      occurring mucosal breaks), identify NSAID damage, measure disease activity / severity,
      measure drug response for clinical trials and in practice, and guide medical management for
      the patient's with small bowel Crohn's disease.

      This study will measure the Niv score against CDAI. Since capsule endoscopy assesses mucosal
      disease and not symptoms it is not envisioned that the Niv score will perfectly correlate
      with the Harvey-Bradshaw score. It is envisioned that the Niv score will have the same
      direction. Both of these indices will be determined as part of a multicenter trial. The trial
      design is outlined below.

      The Study

        1. Prospective trial of the Niv score validating score against known activity indices - see
           addendum A for Niv score

        2. Known Crohn's disease patients undergoing capsule endoscopy are identified - see
           addendum B for inclusion/exclusion criteria

        3. Prior to capsule exam, temperature is taken, height and weight measured, bloods are
           drawn for albumin, ESR, HCT, CRP

        4. Prior to capsule exam, symptom/exam questionnaire is completed - see addendum C for
           questionnaire

        5. Capsule exam is performed

        6. CD of de-identified is made at the study site.

        7. Landmarks are confirmed and the small bowel transit time is divided into 2 and labeled
           on thumbnails

        8. CDs are copied

        9. CDs of study patients are provided to blinded readers

           Scoring sheets will be provided to readers - see addendum A

       10. Readers will score the CDs and return the scoring sheets to the principal investigator

       11. Data is collated and analyzed
    

Intervention name(s): Given® Diagnostic System including PillCamTM SB Capsules
Intervention type(s): Device
Intervention description(s): Device for detection of pathologies as a tool in the diagnosis of gastrointestinal disorders.
An ingestible,disposable video camera that transmits high quality images of the small intestinal mucosa
Other intervention name(s): PillCam™SB capsule (Given Imaging Ltd, Yoqneam, Israel)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Capsule endoscopy; Crohn's disease; IBD; Activity score; Small bowel; Crohn's disease of the small bowel in any stage; Recruiting