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.|
|ClinicalTrials.gov Identifier: NCT03955055|
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : June 13, 2019
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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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]
- 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]
- 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
- Re-admission rate [ Time Frame: Enrollment to 720 hours ]Rate of in-patient re-admissions to the hospital
- 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
- Invasive Procedures [ Time Frame: Enrollment to 720 hours ]Number of invasive procedures performed
- Therapeutic Procedures [ Time Frame: Enrollment to 720 hours ]Number of therapeutic procedures performed
- Complication Rates [ Time Frame: Enrollment to 720 hours ]Percentage of participants who experienced a complication.
- Cost of Admission [ Time Frame: Enrollment to 720 hours ]Costs associated with the in-patient admission to the hospital
- Blood Product Transfusions [ Time Frame: Enrollment to one year ]Number of blood products transfused
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955055
|Contact: David R Cave, MD, PhDfirstname.lastname@example.org|
|United States, Massachusetts|
|UMass Memorial Medical Center|
|Worcester, Massachusetts, United States, 01655|
|Principal Investigator:||David R Cave, MD, PhD||UMass Medical School Professor of Medicine|