Status:

COMPLETED

EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging

Lead Sponsor:

Merit Medical Systems, Inc.

Conditions:

Hemorrhage

Bleeding Hemorrhage

Eligibility:

All Genders

18+ years

Brief 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 ...

Eligibility Criteria

Inclusion

  • Age ≥18 years
  • Subject requires embolization and is suitable for treatment with EmboCube in accordance with device Instructions For Use for the treatment of bleeding or hemorrhage.
  • Subject provides written informed consent to study data collection.

Exclusion

  • Bleeding site in the neck, head, or brain.
  • Subject has co-morbidity with survival prognosis of less than 30 days, in the opinion of the treating physician
  • In the investigator's opinion, participation in the study may not be in the subject's best interest.

Key Trial Info

Start Date :

November 30 2022

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 10 2024

Estimated Enrollment :

101 Patients enrolled

Trial Details

Trial ID

NCT05307783

Start Date

November 30 2022

End Date

April 10 2024

Last Update

January 22 2025

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia, 2050

2

South Western Sydney Local Health District

Liverpool, Australia

3

Alfred Health

Sydney, Australia

4

Centre Hospitalier Universitaire de Nîmes - Caremeau

Nîmes, France

EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging | DecenTrialz