Status:
COMPLETED
Wireless Capsule Endoscopy in Ulcerative Colitis
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Prometheus Laboratories
American College of Gastroenterology
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Subjects will undergo both a blood draw and a wireless capsule endoscopy (WCE). The blood draw will occur in the GI procedure unit on the day of subjects exam. WCE: Subject will only consume a clear...
Eligibility Criteria
Inclusion
- Inclusion criteria for the "disease" arm include a clinical impression of ulcerative colitis that includes assessment of the colon by colonoscopy and biopsy and assessment of the terminal ileum either by ileoscopy or by small bowel radiograph or enteroclysis. Subjects in the "control" arm will only be included if they do not carry the diagnosis of UC or CD, have not had previous gastric or small bowel surgery and are free of gastrointestinal symptoms including unexplained abdominal pain, diarrhea or gastrointestinal bleeding.
Exclusion
- A known bowel obstruction, fistula or stricture, a permanent pacemaker and/or implantable defibrillator, history of a swallowing disorder, inability to provide informed consent, pregnancy, the use of aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) within the past 30 days, known celiac disease, known terminal ileal disease on ileoscopy and a history of occult or obscure gastrointestinal bleeding of unclear etiology. In menstruating females, a urine HCG will be performed on the day they arrive for the study (prior to ingestion of the capsule), if fourteen (14) days or more have elapsed since their last menstrual period. If subject reports they are menopausal, a urine HCG will be performed unless subject has had no menses during the past two years.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00145808
Start Date
June 1 2005
End Date
November 1 2008
Last Update
September 5 2013
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637