Bleeding Hemorrhage, Hemorrhage
Conditions
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.
Interventions
DEVICEEmboCube 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
Sponsors
Merit Medical Systems, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Australia, France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Device Treated with EmboCube Embolization Gelatin | 101 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 7 |
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | Device |
|---|---|
| Age, Continuous | 57.1 years STANDARD_DEVIATION 20.37 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 72 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 25 Participants |
| Race/Ethnicity, Customized Race African American / Black | 2 Participants |
| Race/Ethnicity, Customized Race Asian | 6 Participants |
| Race/Ethnicity, Customized Race Caucasian/ White | 40 Participants |
| Race/Ethnicity, Customized Race Not reported / Refuse to disclose | 25 Participants |
| Race/Ethnicity, Customized Race Other | 23 Participants |
| Race/Ethnicity, Customized Race Pacific Islander | 5 Participants |
| Region of Enrollment Australia | 50 Participants |
| Region of Enrollment France | 51 Participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 101 |
| other Total, other adverse events | 3 / 101 |
| serious Total, serious adverse events | 12 / 101 |
Outcome results
Primary
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.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Participants With Clinical Success: Cessation of Bleeding up to 24 Hours | 100 Participants |
Primary
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.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Participants Without Device and Procedure-related AEs (Incidence of Device and Procedure-related AEs) | 101 Participants |