This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback
Trial record 1 of 1 for:    NCT01371591
Previous Study | Return to List | Next Study

Capsule Endoscopy for Hemorrhage in the Emergency Room (CHEER)

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified August 2017 by Andrew C. Meltzer, MD, George Washington University
Information provided by (Responsible Party):
Andrew C. Meltzer, MD, George Washington University Identifier:
First received: June 9, 2011
Last updated: August 1, 2017
Last verified: August 2017
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: Pill Cam, clinical evaluation Device: Pill Cam, archived

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Andrew C. Meltzer, MD, 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 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
Anticipated Study Start Date: August 1, 2017
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  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 identifier: NCT01371591

United States, District of Columbia
George Washington University Hospital Not yet recruiting
Washington, D.C., District of Columbia, United States, 20037
Contact: Lorna Richards    202-741-2917   
Sponsors and Collaborators
Andrew C. Meltzer, MD
Principal Investigator: Andrew C Meltzer, MD George Washington University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Andrew C. Meltzer, MD, Principal Investigator, George Washington University Identifier: NCT01371591     History of Changes
Other Study ID Numbers: GWIRB#: 080933
Study First Received: June 9, 2011
Last Updated: August 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Andrew C. Meltzer, MD, George Washington University:

Additional relevant MeSH terms:
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
Signs and Symptoms processed this record on September 21, 2017