Wireless Capsule Endoscopy in Small-Bowel Crohn's Disease

Phase 1

Withdrawn

• Conditions: Crohn's Disease

• Registration Number: NCT00178438
• Lead Sponsor: University of Rochester

Brief Summary

The purpose of this study is to determine the best role for capsule endoscopy in diagnosing Crohn's disease.

Detailed Description

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.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Study Completion: 2006-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-16
• Last Update Posted: 2015-09-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Compare capsule endoscopy (CE) finding with traditional findings (colonoscopy and small-bowel follow through [SBFT]) in patients with known Crohn's disease

Secondary Outcome Measures

Name	Time	Method
Evaluate the extent and severity of CE determined small-bowel involvement in patients with known Crohn's disease

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States