EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging

Completed

• Conditions: Bleeding Hemorrhage; Hemorrhage

• Registration Number: NCT05307783
• Lead Sponsor: Merit Medical Systems, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-23
• Study First Submitted QC: 2022-03-23
• Study First Posted: 2022-04-01
• Study Start: 2022-11-30
• Primary Completion: 2024-03-15
• Study Completion: 2024-04-10
• Results First Submitted: 2024-09-18
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-20
• Last Update Submitted: 2025-01-20
• Results First Posted: 2025-01-22
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinical Success: Cessation of Bleeding up to 24 Hours	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)	24 hours	Absence of unanticipated serious adverse device effects within 24 hours.

Trial Locations

Locations (5)

HEGP; 🇫🇷 Paris, France

Alfred Health; 🇦🇺 Sydney, Australia

South Western Sydney Local Health District; 🇦🇺 Liverpool, Australia

Chris O'Brien Lifehouse; 🇦🇺 Camperdown, New South Wales, Australia

Centre Hospitalier Universitaire de Nîmes - Caremeau; 🇫🇷 Nîmes, France