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Procedure

Experimental for Upper Gastrointestinal Bleeding (CHEER Trial)

N/A
Waitlist Available
Led By Andrew Meltzer, MD
Research Sponsored by George Washington University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Individuals aged ≥ 18 years presenting to the Emergency Department with likely upper GI bleed (bloody emesis and/or coffee ground vomiting and/or melena) that has occurred within the previous 48 hours.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

Summary

This is a multi-center randomized controlled trial examining the use of Video Capsule Endoscopy (VCE) to discharge low-moderate risk patients with suspected upper gastrointestinal bleeds (UGIB) from the Emergency Department (ED.) The investigators will enroll 100 subjects at 4 sites who present with signs of hemodynamically stable UGIBs and compare VCE risk assessment to an Active Control (AC) group who receive inpatient upper endoscopy (EGD).

Eligible Conditions
  • Upper Gastrointestinal Bleeding

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Discharged for Outpatient Management of Upper GI Bleeds
Secondary outcome measures
Detection Rate of Video Capsule Endoscopy
Other outcome measures
Number of Participants With Serious Adverse Events at Day 7 and Day 30

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 Intervention
Subject will have Video Capsule Endoscopy read during ED length of stay, disposition will be determined using Capsule Endoscopy Risk Assessment.
Group II: Active ControlActive Control2 Interventions
Video Capsule Endoscopy will be administered during ED, but video will not be read until after inpatient EGD. Subject will have hospital admission with an EGD conducted during hospital stay.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PillCam UGI
2018
N/A
~30

Find a Location

Who is running the clinical trial?

George Washington UniversityLead Sponsor
250 Previous Clinical Trials
458,786 Total Patients Enrolled
MedtronicIndustry Sponsor
613 Previous Clinical Trials
759,709 Total Patients Enrolled
Andrew Meltzer, MDPrincipal InvestigatorGeorge Washington University- Department of Emergency Medicine
1 Previous Clinical Trials
360 Total Patients Enrolled
~3 spots leftby Sep 2025
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