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NCT00178438 Clinical Trial

Wireless Capsule Endoscopy in Small-Bowel Crohn's Disease

Crohn's Disease Clinical Trial

Official title:
A Prospective Trial of Wireless Capsule Endoscopy in Small-Bowel Crohn's Disease

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00178438
Other study ID # RSRB # 10455
Secondary ID
Status Withdrawn
Phase Phase 1/Phase 2
First received September 13, 2005
Last updated September 16, 2015
Start date June 2005
Est. completion date June 2006

Study information
Verified date September 2015
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Capsule Endoscopy

Locations
Country Name City State
United States University of Rochester Medical Center Rochester New York

Sponsors (1)
Lead Sponsor Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Compare capsule endoscopy (CE) finding with traditional findings (colonoscopy and small-bowel follow through [SBFT]) in patients with known Crohn's disease
Secondary Evaluate the extent and severity of CE determined small-bowel involvement in patients with known Crohn's disease
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