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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This study has been withdrawn prior to enrollment.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
History of Changes
  Purpose

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


Condition Intervention Phase
Crohn's Disease
 Device: Capsule Endoscopy
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Trial of Wireless Capsule Endoscopy in Small-Bowel Crohn's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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:
  • Evaluate the extent and severity of CE determined small-bowel involvement in patients with known Crohn's disease

Estimated Enrollment: 100
Study Start Date: June 2005
Estimated Study Completion Date: June 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00178438

Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Parvez S Mantry, MD University of Rochester Medical Center, Digestive and Liver Disease Unit
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00178438     History of Changes
Other Study ID Numbers: RSRB # 10455
Study First Received: September 13, 2005
Last Updated: July 8, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
capsule endoscopy in small bowel

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 16, 2013