NCT05307783

EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging

A Multicenter Observational Study to Evaluate Outcomes of EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 101 (actual)
• Sponsor: Merit Medical Systems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemorrhage
• Bleeding Hemorrhage

Interventions

Type	Name	Description
DEVICE	EmboCube Embolization Gelatin	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

Timeline

• Start date: 2022-11-30
• Primary completion: 2024-03-15
• Completion: 2024-04-10
• First posted: 2022-04-01
• Last updated: 2025-01-22
• Results posted: 2025-01-22

Locations

5 sites across 2 countries: Australia, France

Regulatory

• FDA-regulated device study