We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01006824
Recruitment Status : Completed
First Posted : November 3, 2009
Last Update Posted : January 25, 2011
Sponsor:
Information provided by:
University of Southern California

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 Type : Interventional  (Clinical Trial)
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 : March 2003
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Further bleeding [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Diagnostic yield [ Time Frame: 1 year ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Loren Laine, University of Southern California
ClinicalTrials.gov Identifier: NCT01006824     History of Changes
Other Study ID Numbers: HS-02C010
First Posted: November 3, 2009    Key Record Dates
Last Update Posted: January 25, 2011
Last Verified: January 2011

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