CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 87 enrolled
Drug / intervention
Early Video Capsule Endoscopydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02442830
NCT02442830N/ACompleted

A Comparison of Early Deployment of a Video Capsule (Endocapsule EC-10: Olympus Tokyo. Japan) in the Emergency Department Versus Standard of Care Workup of Non-hematemesis Gastrointestinal Bleeding

University of Massachusetts, Worcester·interventional·Posted May 13, 2015·Updated Aug 7, 2018

In Brief

A clinical study evaluating Early Video Capsule Endoscopy for Melena and Gastrointestinal Hemorrhage. Completed, enrolled 87 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsOlympus Corporation

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 13, 2015
Enrollment StartApr 19, 2015
Primary CompletionJul 2, 2017
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 11.1 years ago

Interventions

Early Video Capsule Endoscopydevice

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.