EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging

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

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 Overview

• Status: Completed
• Conditions: Hemorrhage; Bleeding Hemorrhage
• Intervention / Treatment: Device: EmboCube Embolization Gelatin

• Study Type: Observational
• Enrollment (Actual): 101

Contacts and Locations

Study Locations

• Australia
  • Liverpool, Australia
    • South Western Sydney Local Health District
  • Sydney, Australia
    • Alfred Health
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Chris O'Brien Lifehouse
• France
  • Nîmes, France
    • Centre Hospitalier Universitaire de Nîmes - Caremeau
  • Paris, France
    • HEGP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects who are treated with EmboCube to control bleeding or hemorrhage in accordance with the current approved CE Mark indication for use (IFU) as stated in the IFU.

Description

Inclusion Criteria:

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

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 the opinion of the treating physician
3. In the investigator's opinion, participation in the study may not be in the subject's best interest.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Clinical Success: Cessation of Bleeding up to 24 Hours	The primary performance endpoint will be clinical success defined as cessation of bleeding post-embolization and absence of rebleeding at the treated site requiring reintervention (repeat embolization or additional surgery), within 24 hours.	24 hours
Number of Participants Without Device and Procedure-related AEs (Incidence of Device and Procedure-related AEs)	Absence of unanticipated serious adverse device effects within 24 hours.	24 hours

Collaborators and Investigators

• Sponsor: Merit Medical Systems, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Actual): March 15, 2024
• Study Completion (Actual): April 10, 2024

Study Registration Dates

• First Submitted: March 23, 2022
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: EGE-P4-21-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes