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Clinical Trial Summary

The researcher's primary hypothesis is that VCE allows for safe outpatient management of ED patients with suspected upper GI hemorrhage. A prospective multicenter randomized control trial was designed to investigate the safety of this approach.


Clinical Trial Description

The typical primary care, urgent care or emergency care provider is unable to evaluate common and serious conditions of the gastrointestinal tract such as a bleeding peptic ulcer. As such, more than 80% of patients who present to US ED's with suspected bleeding in their upper GI tract require hospitalization, procedural sedation by an anesthesiologist, and a traditional tube-based upper endoscopy by a gastroenterologist. While this traditional process is safe and effective, it is not efficient for our low-risk patients and not timely for our high-risk patients. The opportunity to bring Video Capsule Endoscopy to the front-lines of US medical care will revolutionize how we manage upper GI bleeding and shed light on critical diseases that have heretofore been hidden from most providers. This trial is an important step toward demonstrating that VCE is a safe and effective tool to risk-stratify upper GI bleeding and improve quality of emergency care for all patients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01371591
Study type Interventional
Source George Washington University
Contact
Status Not yet recruiting
Phase N/A
Start date April 1, 2018
Completion date August 2018

See also
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Active, not recruiting NCT04536428 - ClearEndoclip Versus EZ Clip for Upper Gastrointestinal Ulcer Bleeding N/A