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This study has been withdrawn prior to enrollment.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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014