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Study of Early Endocapsule (EC) in Clinical Decision Unit Versus Standard of Care Work-up for GI Bleeding

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03955055
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : June 13, 2019
Olympus Corporation of the Americas
Information provided by (Responsible Party):
David Cave, University of Massachusetts, Worcester

Brief Summary:

This study will evaluate the use of the Olympus EndoCapsule EC-10 video capsule compared with the standard of care workup for patients in the Clinical Decision Unit who have symptoms of gastrointestinal (GI) bleeding. Patients will be eligible if they have any symptoms of GI bleeding, either vomiting blood or symptoms without vomiting blood.

Patients randomized to the early capsule arm will have an immediate video capsule endoscopy. Patients randomized to the standard of care arm will have no study intervention and will follow the treating physician's diagnostic workup.

The primary goal of the study is to compare how often a source of bleeding is identified in patients in the two groups.

Condition or disease Intervention/treatment Phase
Gastro Intestinal Bleeding Hematemesis Melena Device: Video Capsule Endoscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Randomized Comparison of Early Deployment of a Video Capsule (Endocapsule EC-10: Olympus Tokyo) in Clinical Decision Unit (CDU) Versus Standard of Care (SOC) Work-up of Hematemesis [H] and Non-hematemesis Gastrointestinal Bleeding [NHGIB]
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Early Capsule Group
The intervention for subjects in this arm will be to have a video capsule deployed as soon as possible after presentation to the clinical decision unit. Information from the video capsule will be obtained and reviewed to determine location of bleeding. Once that information has been obtained a decision will be made on which endoscopic test is most pertinent in finding and treating the source of bleeding.
Device: Video Capsule Endoscopy
Patients will swallow a video capsule as soon as possible (immediately or within 10 hours, if patient is not fasting).
Other Name: Olympus EndoCapsule EC-10

No Intervention: Standard of Care Work-up
In this arm, patients will receive "standard of care workup" for non-hematemesis gastrointestinal bleeding. This could include upper endoscopy, colonoscopy, and additional capsule or small bowel enteroscopy depending on the subject's presentation and the results of the workup performed by the gastroenterology team. For patients requiring a video capsule endoscopy as part of "standard of care workup" the patients will be given the same Olympus video capsule that is used in the "Early Capsule" group.

Primary Outcome Measures :
  1. Rate of Detection of Bleeding [ Time Frame: Enrollment to time of detection of bleeding as measured in hours, up to 720 hours, whichever is sooner ]
    Rate of detection of active bleeding or stigmata of recent bleeding [blood clot or visible vessel]

  2. Time to Detection of Bleeding [ Time Frame: Enrollment to time of detection of bleeding as measured in hours, up to 720 hours, whichever is sooner ]
    Time to detection of active bleeding or stigmata of recent bleeding [blood clot or visible vessel]

Secondary Outcome Measures :
  1. Admission rate [ Time Frame: Enrollment to time of admission as measured in hours, up to 720 hours, whichever is sooner ]
    Rate of in-patient admissions to the hospital

  2. Re-admission rate [ Time Frame: Enrollment to 720 hours ]
    Rate of in-patient re-admissions to the hospital

  3. Hospital Length of Stay [ Time Frame: Enrollment to time of discharge as measured in hours, up to 720 hours, whichever is sooner ]
    Length of hospital stay measured in hours

  4. Invasive Procedures [ Time Frame: Enrollment to 720 hours ]
    Number of invasive procedures performed

  5. Therapeutic Procedures [ Time Frame: Enrollment to 720 hours ]
    Number of therapeutic procedures performed

Other Outcome Measures:
  1. Complication Rates [ Time Frame: Enrollment to 720 hours ]
    Percentage of participants who experienced a complication.

  2. Cost of Admission [ Time Frame: Enrollment to 720 hours ]
    Costs associated with the in-patient admission to the hospital

  3. Blood Product Transfusions [ Time Frame: Enrollment to one year ]
    Number of blood products transfused

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

Inclusion Criteria:

  • Age greater than 18 years old
  • New onset of hematemesis, melena or hematochezia
  • Able to sign consent
  • Hemodynamically stable (that is, blood pressure >100/60 or pulse <110 at the time of consent)
  • Emergency Department must plan to admit patient to the hospital or Clinical Decision Unit
  • If patients have pacemakers and/or implantable cardioverter defibrillator (ICD), they will be placed on telemetry

Exclusion Criteria:

  • adults unable to consent
  • individuals who are not yet adults (infants, children, teenagers)
  • pregnant women
  • prisoners
  • prior history of gastroparesis
  • prior history of gastric or small bowel surgery
  • prior history of inflammatory bowel disease
  • concern for infectious colitis
  • evidence of dysphagia at the time of presentation
  • presence of small amounts of bright red blood per rectum
  • allergy to metoclopramide or erythromycin
  • code status of do not resuscitate/do not intubate (DNR/DNI) or comfort measures only (CMO)
  • prior history of abdominal radiation
  • abdominal pain suggesting an acute abdomen or obstruction.
  • patients who cannot undergo surgery

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): NCT03955055

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Contact: David R Cave, MD, PhD 774-442-4098

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United States, Massachusetts
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
David Cave
Olympus Corporation of the Americas
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Principal Investigator: David R Cave, MD, PhD UMass Medical School Professor of Medicine

Jawaid S, Gondal B, Singh, A, Marshall C, and Cave D. The epidemiology of gastrointestinal bleeding in an academic emergency department as a basis for reconfiguring the conventional approach to its diagnosis and management. Gastrointestinal Endoscopy 2013;77:Supplement, Page AB483.
Jawaid S, Marya N, Gondal B, Maranda L, Marshall C, Charpentier J, Singh A, Foley A, and Cave D. . A reconsideration of the diagnosis and management of gastrointestinal bleeding based on its epidemiology and outcomes analysis. Gastrointestinal Endoscopy 2014;79:Supplement, Page AB231.

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Responsible Party: David Cave, Professor of Medicine, University of Massachusetts, Worcester Identifier: NCT03955055     History of Changes
Other Study ID Numbers: H00015196
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Product Manufactured in and Exported from the U.S.: No

Keywords provided by David Cave, University of Massachusetts, Worcester:
Gastro Intestinal Bleeding

Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms