Wireless Capsule Endoscopy in Small-Bowel Crohn's Disease - Full Text View

Sponsored by:	University of Rochester
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00178438

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 I Phase II

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease Endoscopy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	A Prospective Trial of Wireless Capsule Endoscopy in Small-Bowel Crohn's Disease

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

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

Keywords provided by University of Rochester:

capsule endoscopy in small bowel

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Crohn Disease

Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases

ClinicalTrials.gov processed this record on January 14, 2009