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Capsule Endoscopy for HEmorrhage in the ER (CHEER)

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ClinicalTrials.gov Identifier: NCT03458000
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : January 16, 2019
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Andrew Meltzer, George Washington University

Study Description
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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).

Condition or disease Intervention/treatment Phase
Upper Gastrointestinal Bleeding Device: PillCam UGI Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Capsule Endoscopy for Hemorrhage in the ER
Actual Study Start Date : April 17, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Device: PillCam UGI
An esophageal capsule endoscope which is designed to visualize the upper gastrointestinal tract.
Experimental: Experimental
Subject will have Video Capsule Endoscopy read during ED length of stay, disposition will be determined using Capsule Endoscopy Risk Assessment.
 Device: PillCam UGI
An esophageal capsule endoscope which is designed to visualize the upper gastrointestinal tract.


Outcome Measures
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Primary Outcome Measures :
  1. Patient disposition [ Time Frame: 12 months ]
    Our primary goal is to determine whether ED VCE is able to discharge low risk patients for outpatient management of upper GI bleeds.


Secondary Outcome Measures :
  1. Sensitivity and Specificity of Video Capsule Endoscopy [ Time Frame: 12 months ]
    Our secondary objective is to estimate sensitivity and specificity of VCE compared to subsequent EGD in the detection of serious bleeding lesions in the upper gastrointestinal (GI) tract.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individuals aged 18 years or older presenting to the Emergency Department with acute overt UGIB, defined as bloody emesis and/or coffee ground vomiting and/or melena within the previous 48 hours.

Exclusion Criteria:

  • Stable for discharge without further testing (Glasgow Blatchford Score of 0
  • Upper GI bleed with hemodynamic shock (BP <90mmHg and pulse > 120 beats per minute)
  • Active hematemesis
  • High- Risk Upper GI Bleed (Glasgow Blatchford Score greater than or equal to 6)
  • Known history of gastric cancer
  • Known history of gastric or esophageal varices
  • GI surgery within the last 6 months
  • Dysphagia, swallowing disorder, Zencker' s diverticulum, suspected bowel obstruction or perforation.
  • Gastroparesis, Gastric outlet obstruction, Crohn's disease, past UGI tract surgery
  • Pregnancy/ lactation
  • Altered mental status (e.g., hepatic encephalopathy) that limits the ability to swallow a capsule
  • Expected to have Magnetic Resonance Imaging examination within 7 days
  • On medications that may coat the upper GI tract such as antacids or sucralfate or Maalox.
  • 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
  • Prisoner
  • Non-English Speaker
  • Suspected small bowel or lower GI Bleeding
  • Unable to follow up with confirmatory EGD.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458000


Contacts
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Contact: Andrew Meltzer, MD 202-741-2952 ameltzer@mfa.gwu.edu
Contact: Maxine Le Saux, BS 202-741-2917 mlesaux@mfa.gwu.edu

Locations
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United States, District of Columbia
George Washington University Recruiting
Washington, District of Columbia, United States, 20037
Contact: Andrew Meltzer, MD    202-741-2952    ameltzer@mfa.gwu.edu   
Contact: Maxine Le Saux, BS    202-741-2917    mlesaux@mfa.gwu.edu   
Principal Investigator: Andrew Meltzer, MD         
United States, North Carolina
Duke University School of Medicine Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Alexander T Limkakeng, MD, MHSc       alexander.limkakeng@duke.edu   
Principal Investigator: Alexandar T Limkakeng, MD, MHSc         
United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Nina Gentile, MD         
Sub-Investigator: Dan delPortal, MD         
Principal Investigator: Nina Gentile, MD         
Sponsors and Collaborators
George Washington University
Medtronic
Investigators
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Principal Investigator: Andrew Meltzer, MD George Washington University- Department of Emergency Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Andrew Meltzer, Principal Investigator, George Washington University
ClinicalTrials.gov Identifier: NCT03458000    
Obsolete Identifiers: NCT01371591
Other Study ID Numbers: ISR-2016-10770
IRB #041707 ( Other Identifier: George Washington University Institutional Review Board )
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases