Trial of Wireless Capsule Endoscopy in the Evaluation of Obscure Gastrointestinal Bleeding

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2009-09-30

Brief Summary

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This study compares wireless capsule endoscopy (patients swallow a pill-size camera that sends pictures of the intestine to a recorder worn on their belt) to an x-ray study (called dedicated small bowel contrast radiography) in patients who have bleeding from the gastrointestinal tract without a source of the bleeding identified on routine endoscopic examinations of the esophagus (food pipe), stomach, small intestine, and large intestine.

The investigators hope to determine if the capsule is a better test in terms of decreasing further bleeding, decreasing the need for further diagnostic testing, and decreasing the need for blood transfusions and time spent in the hospital.

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Detailed Description

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Conditions

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Obscure Gastrointestinal Bleeding (Occult or Overt)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Capsule Endoscopy

Group Type EXPERIMENTAL

Capsule endoscopy

Intervention Type OTHER

Capsule endoscopy

2

Dedicated small bowel contrast radiography

Group Type ACTIVE_COMPARATOR

Dedicated small bowel contrast radiography

Intervention Type OTHER

Dedicated small bowel contrast radiography

Interventions

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Capsule endoscopy

Intervention Type OTHER

Dedicated small bowel contrast radiography

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Iron deficiency anemia in men or post-menopausal women and positive fecal occult blood test in pre-menopausal women with nondiagnostic upper endoscopy, colonoscopy, and push enteroscopy.
2. Persistent or recurrent melena or hematochezia with nondiagnostic upper endoscopy, colonoscopy, and push enteroscopy.

Exclusion Criteria

1. Known or suspected GI tract obstruction
2. Severe motility disorders (e.g., achalasia, gastroparesis, pseudoobstruction)
3. Pregnancy
4. Cardiac pacemaker or implanted electro-medical devices

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No