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 range18 Years

SexALL

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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

What they're measuring

Rate of Detection of Bleeding

Timeframe: Enrollment to time of detection of bleeding as measured in hours, up to 720 hours, whichever is sooner

Time to Detection of Bleeding

Timeframe: Enrollment to time of detection of bleeding as measured in hours, up to 720 hours, whichever is sooner

Trial details

NCT IDNCT03955055

SponsorChristopher Marshall

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-09

Results submitted2023-06-02