Capsule Endoscopy for HEmorrhage in the ER
CHEER
Capsule Endoscopy for Hemorrhage in the ER
2 other identifiers
interventional
24
1 country
3
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2018
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2018
CompletedFirst Posted
Study publicly available on registry
March 8, 2018
CompletedStudy Start
First participant enrolled
April 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 7, 2020
CompletedResults Posted
Study results publicly available
June 1, 2023
CompletedJune 1, 2023
May 1, 2023
1.9 years
March 1, 2018
October 22, 2021
May 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Discharged for Outpatient Management of Upper GI Bleeds
Our primary goal is to determine whether ED VCE is able to discharge low risk patients for outpatient management of upper GI bleeds.
30 Days
Secondary Outcomes (1)
Detection Rate of Video Capsule Endoscopy
30 Days
Other Outcomes (5)
Patient Satisfaction With VCE Procedure
30 Days
GI Physician Final Read and Site Physician Agreement on VCE Results
30 Days
Number of Participants With Serious Adverse Events at Day 7 and Day 30
30 Days
- +2 more other outcomes
Study Arms (2)
Active Control
ACTIVE COMPARATORVideo 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.
Experimental
EXPERIMENTALSubject will have Video Capsule Endoscopy read during ED length of stay, disposition will be determined using Capsule Endoscopy Risk Assessment.
Interventions
An esophageal capsule endoscope which is designed to visualize the upper gastrointestinal tract.
Patient was admitted to hospital for care and received in-patient EGD.
Eligibility Criteria
You may qualify if:
- \. 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.
You may not qualify if:
- Upper GI Bleed with hemodynamic instability (BP\<90 mmHg, pulse\>120 beats per minute, and Hgb \< 9 g/dL)
- High Risk Upper GI Bleed (Glasgow Blatchford Score\* ≥ 6)
- Signs, symptoms or history of liver cirrhosis or liver failure
- Signs, symptoms or history of decompensated heart failure or congestive heart failure
- Presumed Pregnant, trying to conceive or breastfeeding
- Known history of gastric cancer
- Known history of gastric or esophageal varices
- GI surgery within the last 6 months
- Prior enrollment in the CHEER Study
- Prisoner or Ward of State
- Trouble swallowing, suspected bowel obstruction or perforation, per treating clinician
- Past UGI tract surgery (e.g., Bilroth I or II, esophagectomy, gastrectomy, bariatric procedure) that changes Gastrointestinal anatomy
- Known history of gastroparesis, esophageal stricture or Crohn's disease
- Altered mental status that limits the ability to swallow a capsule
- Expected to have Magnetic Resonance Imaging (MRI) examination within 7 days
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- George Washington Universitylead
- Medtroniccollaborator
Study Sites (3)
George Washington University
Washington D.C., District of Columbia, 20037, United States
Duke University School of Medicine
Durham, North Carolina, 27710, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
Related Publications (1)
Meltzer AC, Ali MA, Kresiberg RB, Patel G, Smith JP, Pines JM, Fleischer DE. Video capsule endoscopy in the emergency department: a prospective study of acute upper gastrointestinal hemorrhage. Ann Emerg Med. 2013 Apr;61(4):438-443.e1. doi: 10.1016/j.annemergmed.2012.11.008.
PMID: 23398660DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Andrew Meltzer
- Organization
- George Washington University
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Meltzer, MD
George Washington University- Department of Emergency Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 1, 2018
First Posted
March 8, 2018
Study Start
April 17, 2018
Primary Completion
March 15, 2020
Study Completion
September 7, 2020
Last Updated
June 1, 2023
Results First Posted
June 1, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share