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.

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Key information

Conditions

Hemorrhage Bleeding Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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.

Treatment and study plan

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

Primary outcomes

Number of Participants With Clinical Success: Cessation of Bleeding up to 24 Hours

Time frame: 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.
Number of Participants Without Device and Procedure-related AEs (Incidence of Device and Procedure-related AEs)

Time frame: 24 hours

Absence of unanticipated serious adverse device effects within 24 hours.

Sponsors and collaborators

Lead sponsor

Merit Medical Systems, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Apr 1, 2022
Registry last updated: Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed