Wireless Capsule Endoscopy in Ulcerative Colitis

NCT00145808 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2013-09-05

No results posted yet for this study

Summary

Based on the inaccuracies of the current classification scheme for inflammatory bowel disease (IBD), the failure of surgical pouches and the findings of retrospective observational trials to date, we hypothesize that a significant proportion of patients with UC will have small bowel involvement that will result in a change in diagnosis to CD or the recognition of a new phenotype of IBD. The aim of this study is to determine the prevalence of small bowel pathology in patients diagnosed with UC using WCE. This information will aid in the current efforts to re-classify IBD using improved endoscopic and imaging technologies, genetic information and serologic information.

Conditions

Interventions

DEVICE

Given® Diagnostic System

Sponsors & Collaborators

  • Prometheus Laboratories

    collaborator INDUSTRY
  • American College of Gastroenterology

    collaborator OTHER
  • University of Chicago

    lead OTHER

Principal Investigators

  • David Rubin, MD · University of Chicago

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2007-06-30
Completion
2008-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00145808 on ClinicalTrials.gov