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Comparing Early Capsule Deployment to Current Standard of Care for Management of Gastrointestinal Bleeding

NCT02442830 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2018-08-07

Study results available
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Summary

The objectives of this study are to test whether there are statistically significant differences between the standard of care workup workup of non-hematemesis gastrointestinal bleeding by endoscopy \[upper, lower and other tests\], compared with deployment of a video capsule as the first test followed by the most appropriate endoscopic procedure based on video capsule findings, if needed. The investigators propose to examine differences in time to diagnosis, reduction in numbers of procedures, and length of stay between a standard of care workup protocol and our proposed protocol of early capsule endoscopy deployment.

Conditions

  • Melena
  • Gastrointestinal Hemorrhage

Interventions

DEVICE

Early Video Capsule Endoscopy

The intervention is the use of video capsule endoscopy as the first test in a patient presenting to the ED with active bleeding. The capsule allows for visualization of the entire GI tract. Once a capsule has been given to a study patient, a staff member will use the capsule's real-time viewer to see if there is any active bleeding in the stomach. If bleeding is seen the investigators will pursue an upper endoscopy. If no bleeding is seen a staff member will review the entire findings of the capsule and make a decision regarding which therapeutic measure to pursue.

Sponsors & Collaborators

  • Olympus Corporation

    collaborator INDUSTRY

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • David Cave, MD, PhD · Professor of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-19
Primary Completion
2017-07-02
Completion
2017-07-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02442830 on ClinicalTrials.gov