N/A N=35 Randomized Diagnostic

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

Gastro Intestinal Bleeding · Hematemesis · Melena

Bottom Line

View on ClinicalTrials.gov: NCT03955055 ↗

Enrolled (actual)

Serious AEs

20.6%

Results posted

Jul 2023

Primary outcome: Primary: Rate of Detection of Bleeding — 11; 11 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Video Capsule Endoscopy (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Christopher Marshall
Primary completion: Apr 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Rate of Detection of Bleeding	11; 11	—
PRIMARY Time to Detection of Bleeding	20.9; 17.7	—
SECONDARY Admission Rate	14; 20	—
SECONDARY Re-admission Rate	4; 2	—
SECONDARY Hospital Length of Stay	143.7; 140.9	—
SECONDARY Endoscopic Procedures	1.9; 1.35	—
SECONDARY Therapeutic Procedures	0.29; 0.35	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03955055). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.