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

This study has been completed.
Sponsor:
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT01006824
First received: November 2, 2009
Last updated: January 24, 2011
Last verified: January 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Randomized Controlled Trial of Wireless Capsule Endoscopy in the Evaluation of Obscure Gastrointestinal Bleeding

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Further bleeding [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diagnostic yield [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 136
Study Start Date: March 2003
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006824

Locations
United States, California
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
  More Information

Publications:
Responsible Party: Loren Laine, University of Southern California
ClinicalTrials.gov Identifier: NCT01006824     History of Changes
Other Study ID Numbers: HS-02C010
Study First Received: November 2, 2009
Last Updated: January 24, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
Capsule endoscopy
gastrointestinal hemorrhage

Additional relevant MeSH terms:
Hemorrhage
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 16, 2014