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EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging

NCT05307783 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 101

Last updated 2025-01-22

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Merit Medical Systems, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-30
Primary Completion
2024-03-15
Completion
2024-04-10
FDA Device
Yes

Countries

  • Australia
  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05307783 on ClinicalTrials.gov