EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging

NCT05307783 | Completed Results FDA Device

• 1 other identifier: EGE-P4-21-01
• Study Type: observational
• Target: 101
• Locations: 2 countries
• Sites: 5

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 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

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

EmboCube Embolization Gelatin DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merit Medical Systems, Inc.: lead

Study Sites (5)

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

South Western Sydney Local Health District

Liverpool, Australia

Location

Alfred Health

Sydney, Australia

Location

Centre Hospitalier Universitaire de Nîmes - Caremeau

Nîmes, France

Location

HEGP

Paris, France

Location

Related Publications (1)

• Pellerin O, Frandon J, Schlaphoff G, Copping R, Dean C, Clements W. A multicenter prospective study evaluating use of EmboCube Embolization Gelatin alone or in combination with other embolic agents to control bleeding. CVIR Endovasc. 2025 May 31;8(1):50. doi: 10.1186/s42155-025-00571-w.

  PMID: 40448890 DERIVED

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Vicky Brunk
• Organization: Merit Medical

vicky.brunk@merit.com

(385) 766-9152

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 1, 2022
• Study Start: November 30, 2022
• Primary Completion: March 15, 2024
• Study Completion: April 10, 2024
• Last Updated: January 22, 2025
• Results First Posted: January 22, 2025

Record last verified: 2025-01

Locations

AU (3); FR (2)