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Capsule Endoscopy for Hemorrhage in the Emergency Room (CHEER)

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ClinicalTrials.gov Identifier: NCT01371591
Recruitment Status : Not yet recruiting
First Posted : June 13, 2011
Last Update Posted : February 21, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Andrew Meltzer, George Washington University

Tracking Information
First Submitted Date  ICMJE June 9, 2011
First Posted Date  ICMJE June 13, 2011
Last Update Posted Date February 21, 2018
Estimated Study Start Date  ICMJE April 1, 2018
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
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
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT01371591 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Capsule Endoscopy for Hemorrhage in the Emergency Room
Official Title  ICMJE Pilot Study to Investigate the Use of Wireless Capsule Endoscopy for Emergency Department Patients With Suspected Acute Upper Gastrointestinal Bleeding
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Melena
  • Hematemesis
  • Peptic Ulcer Hemorrhage
  • Variceal Hemorrhage
Intervention  ICMJE
  • 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)
  • 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)
Study Arms  ICMJE
  • 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.
    Intervention: Device: Pill Cam, clinical evaluation
  • 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.
    Intervention: Device: Pill Cam, archived
Publications * Meltzer AC, Ali MA, Kresiberg RB, Patel G, Smith JP, Pines JM, Fleischer DE. Video capsule endoscopy in the emergency department: a prospective study of acute upper gastrointestinal hemorrhage. Ann Emerg Med. 2013 Apr;61(4):438-443.e1. doi: 10.1016/j.annemergmed.2012.11.008.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 16, 2016)
100
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2011)
25
Estimated Study Completion Date  ICMJE August 2018
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01371591
Other Study ID Numbers  ICMJE GWIRB#: 080933
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Andrew Meltzer, George Washington University
Study Sponsor  ICMJE Andrew Meltzer
Collaborators  ICMJE Medtronic
Investigators  ICMJE
Principal Investigator: Andrew C Meltzer, MD George Washington University
PRS Account George Washington University
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP