Capsule Endoscopy for Hemorrhage in the Emergency Room (CHEER)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Given Imaging Ltd.
Information provided by (Responsible Party):
George Washington University
ClinicalTrials.gov Identifier:
NCT01371591
First received: June 9, 2011
Last updated: August 17, 2015
Last verified: June 2011
  Purpose

The investigators propose to study the use of video capsule endoscopy (VCE) in the emergency department (ED) for the early assessment of acute upper gastrointestinal hemorrhage (UGIH). This pilot study will investigate the concept that VCE can be used in the ED and is useful for the diagnosis and treatment of patients with suspected UGIH.

The specific endpoints that are planned include the following: (1) the detection of UGIH; (2) the presence of fresh blood; (3) and subject tolerance. An ED attending and an expert gastroenterologist will independently interpret the VCE and make determinations regarding the planned endpoints. Their respective determinations will be compared to each other and to subsequent esophagogastroduodenoscopy (EGD).


Condition Intervention
Melena
Hematemesis
Peptic Ulcer Hemorrhage
Variceal Hemorrhage
Device: Video capsule endoscopy (Pillcam Eso2)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Study to Investigate the Use of Wireless Capsule Endoscopy for Emergency Department Patients With Suspected Acute Upper Gastrointestinal Bleeding

Resource links provided by NLM:


Further study details as provided by George Washington University:

Primary Outcome Measures:
  • Can Video Capsule Endoscopy (VCE) diagnose Upper gastrointestinal hemorrhage (UGIH) in the Emergency Department (ED). [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Our primary question is whether VCE can diagnose UGIH in the acute setting. We will compare the results of the VCE to a subsequent esophogastroduodenscopy (EGD) and measure the accuracy of the ED physician compared to the accuracy of the gastroenterologist.

  • the presence of fresh blood [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Can VCE detect presence of fresh blood?

  • the site of the bleeding [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Can VCE determine the site of bleeding?

  • the etiology of the bleeding [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Can VCE determine the cause of bleeding?

  • patient tolerance of test [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Can patient tolerate the pill cam?


Estimated Enrollment: 50
Study Start Date: March 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Suspected upper GI bleeding
Patients who present to the ED with signs and symptoms highly suggestive of upper gastrointestinal bleeding.
Device: Video capsule endoscopy (Pillcam Eso2)
Administration of wireless video capsule in the ED.
Other Name: Pillcam Eso2

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients greater than 18.
  • Patients presenting with actual or reported hematemesis or coffee ground emesis or melena.

Exclusion Criteria:

  • Refusal to participate
  • Patient is hemodynamically unstable
  • People with dysphagia or another swallowing disorder
  • Pacemaker
  • Known or suspected gastrointestinal obstruction, stricture or fistula
  • Prisoners
  • Patient lacks the ability to give informed consent
  • High suspicion of pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371591

Locations
United States, District of Columbia
George Washington University Hospital
Washington, District of Columbia, United States, 20037
Sponsors and Collaborators
George Washington University
Given Imaging Ltd.
Investigators
Principal Investigator: Andrew C Meltzer, MD George Washington University
  More Information

No publications provided by George Washington University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT01371591     History of Changes
Other Study ID Numbers: GWIRB#: 080933
Study First Received: June 9, 2011
Last Updated: August 17, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by George Washington University:
Bleeding
gastrointestinal
hemorrhage
ulcer
varix
varices
ulcers
GI
stomach
esophagus
duodenum
melena
hematemesis
coffee-ground

Additional relevant MeSH terms:
Hematemesis
Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Digestive System Diseases
Duodenal Diseases
Gastrointestinal Diseases
Gastrointestinal Hemorrhage
Intestinal Diseases
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive
Stomach Diseases
Vomiting

ClinicalTrials.gov processed this record on August 27, 2015