Capsule Endoscopy Crohn's Disease Activity Index - Validation Multi Center Study

This study is currently recruiting participants.
Verified December 2012 by Rabin Medical Center
Sponsor:
Collaborators:
Rambam Health Care Campus
Assaf-Harofeh Medical Center
Hillel Yaffe Medical Center
University of Athens
University of Magdeburg
Information provided by (Responsible Party):
Yaron Niv, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00596700
First received: January 8, 2008
Last updated: December 2, 2012
Last verified: December 2012
  Purpose

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

Condition Intervention Phase
Crohn's Disease
Device: Given® Diagnostic System including PillCamTM SB Capsules
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Capsule Endoscopy Crohn's Disease Activity Index - Validation Multi Center Study

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • This prospective study is aimed to evaluate the correlation of capsule endoscopy CECDAI with the CDAI (accepted clinical index) and IBDQ (quality of life questionnaire) in patients suffering from small-bowel Crohn's disease [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Capsule endoscopy investigation and crohn's disease outcome [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: January 2007
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device

Patient preparation procedure will be done according to chapter 4 in the Given Diagnostic System user manual. In brief: to drink only clear liquids beginning 12:00 noon the day before.at least 8 hours (since 12:00 PM) fast prior to the procedure. Patient will undergo a standard capsule endoscopy. Patients will be allowed to drink clear liquids 2 hours post ingestion, and eat 4 hours post ingestion.

Eight hours post ingestion, data recorder will be removed and the patient will be dismissed.

A local experienced reader will review the RAPID video to determine the diagnosis blinded to the results of the standard workup procedures, and to each other results. Results will be recorded in the case report forms. A decoded video will be transferred to the principal investigator for reevaluation

Device: Given® Diagnostic System including PillCamTM SB Capsules

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 Name: PillCam™SB capsule (Given Imaging Ltd, Yoqneam, Israel)

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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 18 years or older and not greater than 80 years suffer from Crohn's Disease of the small bowel, documented by clinical, endoscopical, histopathological and radiological parameters, in any activity stage iof the disease and any treatment
  • Documented written Informed Consent

Exclusion Criteria:

  • Subject suffers from swallowing difficulties
  • Female subject is pregnant or nursing (in case of necessary small bowel series a pregnancy test has to be performed prior to the test)
  • Subject is known to suffer from intestinal obstruction
  • Subject has a cardiac pacemakers or other implanted electro medical devices
  • Patients with more than 40% small bowel resect
  • Subject has any condition, which precludes compliance with study and/or device instructions
  • Subject suffers from life threatening conditions
  • Subject is currently participating in another clinical study
  • Subject with colonic involvement of Crohn's disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00596700

Contacts
Contact: Yaron Niv, MD, AGAF 972-3-9377237 yniv@clalit.org.il
Contact: Tami Lederfein, BSc 972-3-9277237 yniv@clalit.org.il

Locations
Ireland
Triniti College Recruiting
Dublin, Ireland
Contact: Coln O'Morain, Prof.       comgast@indigo.ie   
Contact: Sarah O'Donnel, Dr.       odonnes2@tcd.ie   
Principal Investigator: Coln O'Morain, Prof.         
Sub-Investigator: Sarah O'Donnel, Dr.         
Israel
Hillel Jafa Medical Center Recruiting
Hadera, Israel
Contact: Zvi Fireman, Prof.       fierman@hy.health.gov.il   
Contact: Elisabeth       LiesMa@hy.health.gov.il   
Principal Investigator: Zvi Fireman, Prof.         
Rabin Medical Center, Beilinson Hospital, Tel Aviv University Recruiting
Petach Tikva, Israel, 49100
Contact: Yaron Niv, MD AGAF    972-3-9377237    yniv@clalit.org.il   
Contact: Tami R Lederfein, BSc    972-3-9377040    tamila@clalit.org.il   
Principal Investigator: Yaron Niv, MD AGAF         
Sub-Investigator: Eyal Gal, MD         
Asaf Harofe Medical Center Recruiting
Zrifin, Israel
Contact: Eytan Scapa, Prof.       escapa@asaf.health.gov.il   
Contact: Hani , SC    972-8-9779655    'haniv@asaf.health.gov.co.il'   
Principal Investigator: Eytan Scapa, Prof.         
Sponsors and Collaborators
Rabin Medical Center
Rambam Health Care Campus
Assaf-Harofeh Medical Center
Hillel Yaffe Medical Center
University of Athens
University of Magdeburg
Investigators
Principal Investigator: Yaron Niv, MD, AGAF RMC, Tel Aviv University
  More Information

No publications provided

Responsible Party: Yaron Niv, Director Department of Gastroenterology, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00596700     History of Changes
Other Study ID Numbers: CECDAI-2006
Study First Received: January 8, 2008
Last Updated: December 2, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
Capsule endoscopy
Crohn's disease
IBD
Activity score
Small bowel
Crohn's disease of the small bowel in any stage
Recruiting

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 17, 2014