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Capsule Endoscopy for Hemorrhage in the Emergency Room (CHEER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01371591
Recruitment Status : Unknown
Verified February 2018 by Andrew Meltzer, George Washington University.
Recruitment status was:  Not yet recruiting
First Posted : June 13, 2011
Last Update Posted : February 22, 2018
Information provided by (Responsible Party):
Andrew Meltzer, George Washington University

Brief Summary:
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 or disease Intervention/treatment Phase
Melena Hematemesis Peptic Ulcer Hemorrhage Variceal Hemorrhage Device: Pill Cam, clinical evaluation Device: Pill Cam, archived Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The provider evaluating the outcomes will not be aware of what group the patient is in.
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
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Endoscopy

Arm Intervention/treatment
Active Comparator: Pill Cam, clinical evaluation
This group receives standard of care plus "Pill Cam" (Video Capsule Endoscopy, VCE). VCE will be read immediately by site PI or co-PI and by site GI doctor. However, if PillCam appears normal or shows a low-risk problem and the patient is stable medically, then the patient will be discharged home. If the patient is discharged, patient will be called to get an endoscopy as an outpatient within 3 days. Patient will be monitored for a minimum of 4 hours. Repeat CBC every 4 hours. If the patient has stable Blood Pressure and pulse for 4 plus hours then the subject will be discharged home with a follow up (standard of care) EGD within 3 days.
Device: Pill Cam, clinical evaluation
The Pill Cam, VCE, will be used for clinical decisions. VCE will be read by site PI or co-PI and by site GI doctor.
Other Name: Video Capsule Endoscopy (VCE)

Placebo Comparator: Pill Cam, archived
This group also receives standard of care plus "Pill Cam" (Video Capsule Endoscopy,VCE). VCE video will be archived and read at a later date. Patient 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 will be applied as necessary. All patients in this group will be admitted for next day endoscopy in the hospital. This is standard of care.
Device: Pill Cam, archived
VCE will not be used for clinical decisions. VCE video will be archived and read at a later date.
Other Name: Video Capsule Endoscopy (VCE)

Primary Outcome Measures :
  1. 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 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 :
  1. 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.

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01371591

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United States, District of Columbia
George Washington University Hospital
Washington, District of Columbia, United States, 20037
Contact: Lorna Richards    202-741-2917   
Sponsors and Collaborators
Andrew Meltzer
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Principal Investigator: Andrew C Meltzer, MD George Washington University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Andrew Meltzer, Principal Investigator, George Washington University Identifier: NCT01371591    
Other Study ID Numbers: GWIRB#: 080933
First Posted: June 13, 2011    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Andrew Meltzer, George Washington University:
Additional relevant MeSH terms:
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Peptic Ulcer
Peptic Ulcer Hemorrhage
Disease Attributes
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage
Signs and Symptoms, Digestive