- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03458000
Capsule Endoscopy for HEmorrhage in the ER (CHEER)
Capsule Endoscopy for Hemorrhage in the ER
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Video capsule endoscopy (VCE) was initially approved in 2001 by the Food and Drug Administration. VCE offers potential advantages over traditional EGD including the ability to be performed 24 hours a day without sedation and interpreted at the bedside by emergency physicians. In addition, VCE is much less invasive, is painless, and enables the patient to pursue normal daily activities after the procedure.
Our primary goal is to test whether ED Video Capsule Endoscopy (VCE) is able to safely discharge low risk patients for outpatient evaluation and management. Our secondary objective is 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.
Research Coordinator will screen potential patients with signs of upper GI bleeding. Patients who screen as eligible will be approached about potential interest, to review of inclusion and exclusion criteria, and obtain informed consent. Research Coordinator will calculate traditional risk stratification scores and once enrolled, all subjects will be randomized to either Active Control (AC) [admission plus EGD within hospital stay] or experimental Capsule Endoscopy Risk Assessment (CERA) in ED. Only patients randomized to the experimental arm will receive video capsule endoscopy in the emergency department.Within 2 hours of presenting to the ED, patient will ingest video capsule-- RC will monitor progress on real-time viewer for passage through pylorus. Upon passing the pylorus, we will record 5 more minutes of video or until battery runs out - whichever occurs first. Patient data will be completed using a standardized data collection tool including the following elements: chief complaint of patient, history of present illness, past medical history, pertinent lab findings, current medications, vital signs, focused physical exam findings and all relevant treatments administered during the ED and hospital stay.
For Active Control (AC) group each patient will be admitted. During hospital admission, EGD will be performed on all subjects and hemostasis therapy applied as necessary. The study team decided against mandating that EGD be performed within 24 hours of hospital admission.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Andrew Meltzer, MD
- Phone Number: 202-741-2952
- Email: ameltzer@mfa.gwu.edu
Study Contact Backup
- Name: Maxine Le Saux, BS
- Phone Number: 202-741-2917
- Email: mlesaux@mfa.gwu.edu
Study Locations
-
-
District of Columbia
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Washington, District of Columbia, United States, 20037
- George Washington University
-
-
North Carolina
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Durham, North Carolina, United States, 27710
- Duke University School of Medicine
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140
- Temple University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 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
- Consumed medications within the past 12 hours that may coat the upper GI tract such as antacids or sucralfate or Maalox and potentially limits capsule visualization
- Patient either refuses or is unable to get traditional EGD
- Patient does not have reliable contact information - no phone, no permanent address
- Patient refuses
- Unable to provide written consent
- Non-English speaker
- Suspected middle or lower GI bleeding
- Treating ED Physician is not amenable to admission or discharge based on randomization or Video Capsule Endoscopy results. * As a modification, the GBS Score modified from the traditional GBS score to reduce the Hemoglobin cut-off for 6 points from 10g/dL to 9 g/dL (see Appendix B, CHEER 4; patient screening)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active Control
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.
|
Patient was admitted to hospital for care and received in-patient EGD.
Other Names:
|
Experimental: Experimental
Subject will have Video Capsule Endoscopy read during ED length of stay, disposition will be determined using Capsule Endoscopy Risk Assessment.
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An esophageal capsule endoscope which is designed to visualize the upper gastrointestinal tract.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Discharged for Outpatient Management of Upper GI Bleeds
Time Frame: 30 Days
|
Our primary goal is to determine whether ED VCE is able to discharge low risk patients for outpatient management of upper GI bleeds.
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30 Days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection Rate of Video Capsule Endoscopy
Time Frame: 30 Days
|
Our secondary objective is to present the prevalence of clinical findings in VCE subjects based on gastroenterologist interpretation.
|
30 Days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Length of Stay
Time Frame: 30 days
|
30 days
|
|
Patient Satisfaction With VCE Procedure
Time Frame: 30 Days
|
30 Days
|
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GI Physician Final Read and Site Physician Agreement on VCE Results
Time Frame: 30 Days
|
30 Days
|
|
Number of Participants With Serious Adverse Events at Day 7 and Day 30
Time Frame: 30 Days
|
Assess for mortality, re-bleeding, total blood transfusions, surgery (capsule-specific group)
|
30 Days
|
ED Length of Stay
Time Frame: 30 Days
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30 Days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Andrew Meltzer, MD, George Washington University- Department of Emergency Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ISR-2016-10770
- IRB #041707 (Other Identifier: George Washington University Institutional Review Board)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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