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Capsule Endoscopy for Hemorrhage in the Emergency Room (CHEER)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2016 by George Washington University
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
George Washington University
ClinicalTrials.gov Identifier:
NCT01371591
First received: June 9, 2011
Last updated: December 16, 2016
Last verified: December 2016
  Purpose
The researcher's primary hypothesis is that VCE allows for safe outpatient management of ED patients with suspected upper GI hemorrhage. A prospective multicenter randomized control trial was designed to investigate the safety of this approach.

Condition Intervention
Melena
Hematemesis
Peptic Ulcer Hemorrhage
Variceal Hemorrhage
Device: Experimental Capsule Endoscopy
Device: Standard of Care plus EGD

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel 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:
  • to test whether risk stratification ED Video Capsule Endoscopy (VCE) in the ER leads to decreased need for hospitalization [ Time Frame: 24 hours ]
    Our primary question is whether VCE can diagnose UGIH in the acute setting.is to test whether ED Video Capsule Endoscopy (VCE) in the ER is able to safely discharge low risk patients for outpatient evaluation


Secondary Outcome Measures:
  • to estimate the sensitivity and specificity of VCE compared to subsequent EGD [ Time Frame: 72 ]
    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.


Estimated Enrollment: 100
Study Start Date: March 2017
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Experimental Capsule Endoscopy
Patient will be monitored for a minimum of 4 hours. VCE will be read by site PI or co-PI and by site GI doc. Repeat CBC at q4 hours. Stable BP and pulse for 4 plus hours -> discharge home with follow up EGD within 3 days.
Device: Experimental Capsule Endoscopy
Placebo Comparator: Standard of Care plus EGD

VCE video will be archived and read at a later date. Pt will be admitted. VCE will not be used for clinical decisions.

Same day or next day (<24 hour) Endoscopic examination of the upper GI tract will be offered to all patients within 24 hours, and hemostasis therapy was applied as necessary

Device: Standard of Care plus EGD

Detailed Description:
The typical primary care, urgent care or emergency care provider is unable to evaluate common and serious conditions of the gastrointestinal tract such as a bleeding peptic ulcer. As such, more than 80% of patients who present to US ED's with suspected bleeding in their upper GI tract require hospitalization, procedural sedation by an anesthesiologist, and a traditional tube-based upper endoscopy by a gastroenterologist. While this traditional process is safe and effective, it is not efficient for our low-risk patients and not timely for our high-risk patients. The opportunity to bring Video Capsule Endoscopy to the front-lines of US medical care will revolutionize how we manage upper GI bleeding and shed light on critical diseases that have heretofore been hidden from most providers. This trial is an important step toward demonstrating that VCE is a safe and effective tool to risk-stratify upper GI bleeding and improve quality of emergency care for all patients.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Subject Inclusion Criteria

1. Individuals aged ≥ 18 years 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.

Subject Exclusion Criteria

  1. Upper GI Bleed with hemodynamic shock (BP<90mmHg and pulse>120 per minute)
  2. Active hematemesis
  3. Known history of gastric cancer
  4. Known history of gastric or esophageal varices
  5. GI surgery within the last 6 months
  6. Dysphagia, swallowing disorder, Zencker's diverticulum, suspected bowel obstruction or perforation
  7. Gastroparesis, Gastric outlet obstruction, Crohn's disease, past UGI tract surgery (e.g., Bilroth I or II, esophagectomy, gastrectomy, bariatric procedure)
  8. Other contraindications to VCE per manufacturer (Medtronic)
  9. Pregnancy/ lactation
  10. Prisoner
  11. Altered mental status (e.g., hepatic encephalopathy) that limits the ability to swallow a capsule
  12. Expected to have Magnetic Resonance Imaging examination within 7 days.
  13. On medications that may coat the upper GI tract such as antacids or sucralfate or Maalox.
  14. Patient either refuses or is unable to get traditional EGD.
  15. Patient does not have reliable contact information - no phone, no permanent address.
  16. Patient refuses / chooses to withdraw (at any time) / unable to provide written consent.
  17. Non-English speaker
  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 Recruiting
Washington, District of Columbia, United States, 20037
Contact: Donna Embersit    202-741-2798    dembersit@mfa.gwu.edu   
Sponsors and Collaborators
George Washington University
Medtronic
Investigators
Principal Investigator: Andrew C Meltzer, MD George Washington University
  More Information

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: December 16, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

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:
Emergencies
Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Melena
Hematemesis
Disease Attributes
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on April 28, 2017