At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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]
In Brief
A clinical study evaluating Video Capsule Endoscopy for Gastro Intestinal Bleeding and 2 related conditions. Completed, enrolled 35 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Patients will swallow a video capsule as soon as possible (immediately or within 10 hours, if patient is not fasting).