Clinical Trial: Capsule Endoscopy for Hemorrhage in the Emergency Room

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Pilot Study to Investigate the Use of Wireless Capsule Endoscopy for Emergency Department Patients With Suspected Acute Upper Gastrointestinal Bleeding

Brief 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.

Detailed Summary: 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.
Sponsor: George Washington University

Current Primary Outcome: to test whether risk stratification ED Video Capsule Endoscopy (VCE) in the ER leads to decreased need for hospitalization [ Time Frame: 24 hours ]

Our primary question is whether VCE can diagnose UGIH in the acute setting.is to test whether ED Video Capsule Endoscopy (VCE) in the ER is able to safely discharge low risk patients for outpatient evaluation


Original Primary Outcome:

Current Secondary Outcome: to estimate the sensitivity and specificity of VCE compared to subsequent EGD [ Time Frame: 72 ]

to estimate the sensitivity and specificity of VCE compared to subsequent EGD in the detection of serious bleeding lesions in the upper gastrointestinal (GI) tract.


Original Secondary Outcome:

Information By: George Washington University

Dates:
Date Received: June 9, 2011
Date Started: March 2017
Date Completion: August 2018
Last Updated: December 16, 2016
Last Verified: December 2016