Skip to main content
OpenTrials
Completed

NCT Number: NCT01006824

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obscure Gastrointestinal Bleeding (Occult or Overt) Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

L.A. County + U.S.C. Medical Center

Los Angeles, California, 90033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Persistent or recurrent melena or hematochezia with nondiagnostic upper endoscopy, colonoscopy, and push enteroscopy.

Exclusion criteria

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

Treatment and study plan

Capsule endoscopy

Other

Capsule endoscopy

Dedicated small bowel contrast radiography

Other

Dedicated small bowel contrast radiography

Primary outcomes

  1. Further bleeding

    Time frame: 1 year

Secondary outcomes

  1. Diagnostic yield

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Nov 3, 2009
Registry last updated
Jan 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.