EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging

Last updated: January 20, 2025
Sponsor: Merit Medical Systems, Inc.
Overall Status: Completed

Phase

N/A

Condition

Hemorrhage

Treatment

EmboCube Embolization Gelatin

Clinical Study ID

NCT05307783
EGE-P4-21-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years

  2. Subject requires embolization and is suitable for treatment with EmboCube inaccordance with device Instructions For Use for the treatment of bleeding orhemorrhage.

  3. Subject provides written informed consent to study data collection.

Exclusion

Exclusion Criteria:

  1. Bleeding site in the neck, head, or brain.

  2. Subject has co-morbidity with survival prognosis of less than 30 days, in theopinion of the treating physician

  3. In the investigator's opinion, participation in the study may not be in thesubject's best interest.

Study Design

Total Participants: 101
Treatment Group(s): 1
Primary Treatment: EmboCube Embolization Gelatin
Phase:
Study Start date:
November 30, 2022
Estimated Completion Date:
April 10, 2024

Connect with a study center

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • South Western Sydney Local Health District

    Liverpool,
    Australia

    Site Not Available

  • Alfred Health

    Sydney,
    Australia

    Site Not Available

  • Centre Hospitalier Universitaire de Nîmes - Caremeau

    Nîmes,
    France

    Site Not Available

  • HEGP

    Paris,
    France

    Site Not Available

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