At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Requires embolization suitable for treatment with EmboCube per device Instructions for Use for bleeding or hemorrhage
- ✕Bleeding site in the neck, head, or brain
- ✕Comorbidity with survival prognosis <30 days per treating physician
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter Observational Study to Evaluate Outcomes of EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging
In Brief
An observational study evaluating EmboCube Embolization Gelatin for Hemorrhage and Bleeding Hemorrhage. Completed, enrolled 101 participants across 5 sites in 2 countries.
Detailed Summary
This is a multicenter, observational study of the use of EmboCube Embolization Gelatin to control hemorrhaging and bleeding. The study is designed to enable the collection, analysis, and reporting of data from "real-world" use of EmboCube used in accordance with the Instructions for Use (IFU) associated with the product's CE Mark approval. Data collection will include that relating to safety and effectiveness and the period of observation during which data will be collected will extend from the index procedure through 28 days post procedure.
Study Details
Timeline
Interventions
EmboCube is a uniformly cut gelatin foam pre-loaded into a syringe, indicated for use in embolization of blood vessels to occlude blood flow to control bleeding/hemorrhaging in the peripheral vasculature