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

Primary Purpose

Obscure Gastrointestinal Bleeding (Occult or Overt)

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Capsule endoscopy
Dedicated small bowel contrast radiography
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obscure Gastrointestinal Bleeding (Occult or Overt) focused on measuring Capsule endoscopy, gastrointestinal hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Capsule Endoscopy

Dedicated small bowel contrast radiography

Outcomes

Primary Outcome Measures

Further bleeding

Secondary Outcome Measures

Diagnostic yield

Full Information

First Posted
November 2, 2009
Last Updated
January 24, 2011
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT01006824
Brief Title
Trial of Wireless Capsule Endoscopy in the Evaluation of Obscure Gastrointestinal Bleeding
Official Title
Randomized Controlled Trial of Wireless Capsule Endoscopy in the Evaluation of Obscure Gastrointestinal Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Southern California

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obscure Gastrointestinal Bleeding (Occult or Overt)
Keywords
Capsule endoscopy, gastrointestinal hemorrhage

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Capsule Endoscopy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Dedicated small bowel contrast radiography
Intervention Type
Other
Intervention Name(s)
Capsule endoscopy
Intervention Description
Capsule endoscopy
Intervention Type
Other
Intervention Name(s)
Dedicated small bowel contrast radiography
Intervention Description
Dedicated small bowel contrast radiography
Primary Outcome Measure Information:
Title
Further bleeding
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Diagnostic yield
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loren Laine, M.D.
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
L.A. County + U.S.C. Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20138043
Citation
Laine L, Sahota A, Shah A. Does capsule endoscopy improve outcomes in obscure gastrointestinal bleeding? Randomized trial versus dedicated small bowel radiography. Gastroenterology. 2010 May;138(5):1673-1680.e1; quiz e11-2. doi: 10.1053/j.gastro.2010.01.047. Epub 2010 Feb 2.
Results Reference
result

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

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