Wireless Capsule Endoscopy in Small-Bowel Crohn's Disease

This study has been withdrawn prior to enrollment.
(Unknown)
Sponsor:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00178438
First received: September 13, 2005
Last updated: July 8, 2008
Last verified: July 2008

September 13, 2005
July 8, 2008
June 2005
Not Provided
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 ClinicalTrials.gov Archive Site
Evaluate the extent and severity of CE determined small-bowel involvement in patients with known Crohn's disease
Evaluate the extent and severity of CE determined small-bowel involvement in patients with known Crohn’s disease
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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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
100
June 2006
Not Provided

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00178438
RSRB # 10455
Not Provided
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University of Rochester
Not Provided
Principal Investigator: Parvez S Mantry, MD University of Rochester Medical Center, Digestive and Liver Disease Unit
University of Rochester
July 2008

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