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

NCT00596700 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-04-29

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • US Department of Veterans Affairs

    collaborator FED

  • Rambam Health Care Campus

    collaborator OTHER

  • Assaf-Harofeh Medical Center

    collaborator OTHER_GOV

  • Hillel Yaffe Medical Center

    collaborator OTHER_GOV

  • University of Athens

    collaborator OTHER

  • University of Magdeburg

    collaborator OTHER

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Yaron Niv, MD, AGAF · RMC, Tel Aviv University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Ireland
  • Israel

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00596700 on ClinicalTrials.gov