Wireless Capsule Endoscopy in Small-Bowel Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00178438
Recruitment Status : Withdrawn
First Posted : September 15, 2005
Last Update Posted : September 18, 2015
Information provided by:
University of Rochester

September 13, 2005
September 15, 2005
September 18, 2015
June 2005
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Compare capsule endoscopy (CE) finding with traditional findings (colonoscopy and small-bowel follow through [SBFT]) in patients with known Crohn's disease
Compare CE finding with traditional findings (colonoscopy and SBFT) in patients with known Crohn’s disease
Complete list of historical versions of study NCT00178438 on Archive Site
Evaluate the extent and severity of CE determined small-bowel involvement in patients with known Crohn's disease
Same as current
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Wireless Capsule Endoscopy in Small-Bowel Crohn's Disease
A Prospective Trial of Wireless Capsule Endoscopy in Small-Bowel Crohn's Disease
The purpose of this study is to determine the best role for capsule endoscopy in diagnosing Crohn's disease.
Wireless capsule endoscopy (CE) is a Food and Drug Administration (FDA) approved technology that allows viewing of the entire small-bowel. Capsule endoscopy involves swallowing a pill-sized camera that sends images to a data recorder worn on a vest. Because Crohn's disease (CD) often involves the small bowel, we would like to find out if capsule endoscopy is useful in diagnosing small-bowel Crohn's disease. Current methods for diagnosing small-bowel Crohn's disease include colonoscopy, esophagogastroduodenoscopy (EGD), enteroscopy (ENT), single contrast barium small-bowel follow through (SBFT), and double contrast small-bowel enteroclysis (SBE), but these tests are unable to identify the presence or extent of small-bowel disease in many patients.
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Crohn's Disease
Device: Capsule Endoscopy
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2006
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Inclusion Criteria:

  • English speaking adult patients (>18 years old) with known Crohn's disease

Exclusion Criteria:

  • Severe medical or psychiatric co-morbidities
  • Active swallowing problems
  • Bowel obstruction
  • History of stricture or fistula
  • Pregnancy
  • Taking aspirin/non-steroidal anti-inflammatory drug (NSAID) or potassium chloride (KCl) within 4 weeks prior to the colonoscopy and anytime after colonoscopy
  • Inability to consent
  • Exclusion of patients whose colonoscopy was done for reasons other than signs/symptoms suggestive of Crohn's disease
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
RSRB # 10455
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University of Rochester
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Principal Investigator: Parvez S Mantry, MD University of Rochester Medical Center, Digestive and Liver Disease Unit
University of Rochester
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP