EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging

Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05307783
• Other study ID #: EGE-P4-21-01
• Status: Recruiting
• Start date: November 30, 2022
• Est. completion date: August 2024

Study information

• Verified date: October 2023
• Source: Merit Medical Systems, Inc.
• Contact: Irene Coughlin
• Phone: 13857669133
• Email: irene.coughlin[@]merit.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bleeding Hemorrhage
• Hemorrhage

Intervention

Device:
• EmboCube Embolization Gelatin
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

Locations

Country	Name	City	State
Australia	Chris O'Brien Lifehouse	Camperdown	New South Wales
Australia	South Western Sydney Local Health District	Liverpool
Australia	Alfred Health	Sydney
France	Centre Hospitalier Universitaire de Nîmes - Caremeau	Nîmes
France	HEGP	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Merit Medical Systems, Inc.

Countries where clinical trial is conducted

Australia,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidence of device and procedure-related AEs	Absence of unanticipated serious adverse device effects within 24 hours.	24 hours