Wireless Capsule Endoscopy in Small-Bowel Crohn's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2006-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Crohn's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Capsule Endoscopy

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes