EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging
Sponsored by Merit Medical Systems, Inc.
About this trial
Last updated a year ago
Study ID
EGE-P4-21-01
Status
Completed
Type
Observational
Placebo
No
Accepting
18+ Years
All Sexes
Trial Timing
Ended 2 years ago
What is this trial about?
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.
What are the participation requirements?
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.