Evaluation of Capsule Endoscopy in Patients With Suspected Crohn's Disease

Completed · Not applicable

Conditions studied: Crohn's Disease

In brief

The aim of this study is to validate the ability of Capsule Endoscopy (CE) to accurately diagnose small bowel (SB) Crohns disease in patients with symptoms of abdominal pain and diarrhea. The primary objective of the study is to evaluate whether Capsule Endoscopy prior to colonoscopy will improve diagnosis in patients with suspected Crohns disease when compared to standard diagnostic testing.

Key facts

Study ID

NCT00487396

Run by

Medtronic - MITG

People needed

98

Starts

2007-09-01

Expected to finish

2010-11-01

Last updated by the study team

2020-10-22

Who can join

Age: 10 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients ages 10-65 years, inclusive
• Patient suffers from either
• diarrhea for more than 6 weeks and less than 3 years and/or
• abdominal pain for more than 6 weeks and less than 3 years and/or
• extra-luminal manifestations of IBD including: erythema nodosum, pyoderma gangrenosum, arthritis, peri-anal disease, uveitis, aphthous stomatitis
• Patient suffers from at least one of the symptoms / lab abnormalities listed below:
• Positive inflammatory marker (ESR, CRP, thrombocytosis, leukocytosis, fecal lactoferrin, fecal alpha-1 antitrypsin) within 3 months prior to enrollment
• Unexplained anemia (less than normal limits) within 3 months prior to enrollment
• Hypoalbuminemia (<3.5 g/dl) within 3 months of enrollment
• Positive ASCA within 3 months of enrollment
• Abnormal white blood cell scan with in 3 months of enrollment
• Stool negative for O\&P (C\&S) within 3 months of enrollment
• Recurrent Fevers
• Unexplained weight loss, failure to thrive in children
• Gastro-intestinal bleeding including melena and/or hematochezia and/or FOBT positive.
• Chronic perianal disease (fistula, fissure, peri-rectal abscess)
• Abnormal small bowel SBFT and/or enteroclysis and/or abdominal CT not conclusively diagnostic for IBD
• Patient is indicated for Ileo-Colonoscopy
• Patient or legal guardian agrees to sign consent form

You may not qualify if…

• Indeterminate Colitis where the purpose is only to make a definitive diagnosis and where the inclusion criteria are not otherwise met
• Known intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting.
• Definite long stricture seen on radiological exam.
• Suspected GI stricture, followed by agile™ study that could not prove patency of the GI tract.
• Known history of small bowel Crohn's Disease
• Current treatment for active IBD
• Positive Anti-tTG or anti-endomysial antibody
• Any of the following work-up within 1 year of study entry: Capsule Endoscopy, Colonoscopy and Upper GI/SBFT.
• Non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or more) during the 4 weeks preceding enrollment
• Patient is pregnant

Where it is running

• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• Atlanta Gastroenterology — Atlanta, Georgia, United States
• Stan Cohen — Atlanta, Georgia, United States
• John Hopkins - Department of Medicine — Baltimore, Maryland, United States
• UMass Memorial Medical Center — Worcester, Massachusetts, United States
• Minnesota Gastroenterology Associates — Plymouth, Minnesota, United States
• Private Practice — New York, New York, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• McGill University Health Center — Montreal, Quebec, Canada
• Rambam Medical Center — Haifa, Israel
• Malmo University Hospital UMAS — Malmö, Sweden

Full record on ClinicalTrials.gov

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