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

• Sponsor: University of Southern California (Other)
• Overall Status: Completed
• CT.gov ID: NCT01006824
• Collaborator: (none)
• Enrollment: 136
• Location: 1
• Arms: 2
• Duration (Months): 78.1
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Obscure Gastrointestinal Bleeding (Occult or Overt)	Other: Capsule endoscopy; Other: Dedicated small bowel contrast radiography	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 136 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Randomized Controlled Trial of Wireless Capsule Endoscopy in the Evaluation of Obscure Gastrointestinal Bleeding
• Study Start Date: Mar 1, 2003
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Capsule Endoscopy	Other: Capsule endoscopy; Capsule endoscopy
Active Comparator: 2 Dedicated small bowel contrast radiography	Other: Dedicated small bowel contrast radiography; Dedicated small bowel contrast radiography

Outcome Measures

Primary Outcome Measures

1. Further bleeding [1 year]

Secondary Outcome Measures

1. Diagnostic yield [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	L.A. County + U.S.C. Medical Center	Los Angeles	California	United States	90033

Sponsors and Collaborators

• University of Southern California

Investigators

• Principal Investigator: Loren Laine, M.D., University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01006824
• Other Study ID Numbers: HS-02C010
• First Posted: Nov 3, 2009
• Last Update Posted: Jan 25, 2011
• Last Verified: Jan 1, 2011

• Keywords provided by , ,: Capsule endoscopy; gastrointestinal hemorrhage
• Additional relevant MeSH terms: Gastrointestinal Hemorrhage; Hemorrhage

Study Results

No Results Posted as of Jan 25, 2011