Comparing Early Capsule Deployment to Current Standard of Care for Management of Gastrointestinal… (NCT02442830) | Clinical Trial Compass
CompletedNot Applicable
Comparing Early Capsule Deployment to Current Standard of Care for Management of Gastrointestinal Bleeding
United States87 participantsStarted 2015-04-19
Plain-language summary
The objectives of this study are to test whether there are statistically significant differences between the standard of care workup workup of non-hematemesis gastrointestinal bleeding by endoscopy \[upper, lower and other tests\], compared with deployment of a video capsule as the first test followed by the most appropriate endoscopic procedure based on video capsule findings, if needed. The investigators propose to examine differences in time to diagnosis, reduction in numbers of procedures, and length of stay between a standard of care workup protocol and our proposed protocol of early capsule endoscopy deployment.
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 melena or hematochezia
* Able to sign consent
* Hemodynamically stable (i.e. blood pressure \>100/60 or pulse \<110 at the time of consent)
* ED must plan to admit patient to the hospital or Clinical Decision Unit.
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 Crohn's disease
* Concern for infectious colitis
* Non-English speaking
* Evidence of dysphagia at the time of presentation
* Presence of bright red blood per rectum concerning for hemorrhoids
* 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
* Presence of Implantable Cardioverter Defibrillator (ICD) or pacemaker or other implanted electronic devices
* Abdominal pain suggesting an acute abdomen or obstruction. In clinical practice, only patients with crampy abdominal pain due to Crohn's disease, previous intestinal surgery and a previous history of radiation therapy require a patency capsule or CT enterography before capsule endoscopy.
* 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
Time to Localization of Bleeding
Timeframe: Enrollment to localization of bleeding as measured in hours, up to 720 hours, whichever is sooner.