Study of Early Endocapsule (EC) in Clinical Decision Unit Versus Standard of Care Work-up for GI … (NCT03955055) | Clinical Trial Compass
CompletedNot Applicable
Study of Early Endocapsule (EC) in Clinical Decision Unit Versus Standard of Care Work-up for GI Bleeding
United States35 participantsStarted 2020-02-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of Detection of Bleeding
Timeframe: Enrollment to time of detection of bleeding as measured in hours, up to 720 hours, whichever is sooner
2
Time to Detection of Bleeding
Timeframe: Enrollment to time of detection of bleeding as measured in hours, up to 720 hours, whichever is sooner