An observational study in Hemorrhage and Bleeding Hemorrhage, sponsored by Merit Medical Systems, Inc.. Completed at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-22.
Sponsored by Merit Medical Systems, Inc. · Observational
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.
3,011 studies on the registry are indexed under Hemorrhage; 466 are open to participants now.
This study's enrollment of 101 is below the median of 150 across 897 observational studies indexed under Hemorrhage.
Browse Hemorrhage studies →Merit Medical Systems, Inc. is the lead sponsor of 29 studies on the registry; 4 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects who are treated with EmboCube to control bleeding or hemorrhage in accordance with the current approved CE Mark indication for use (IFU) as stated in the IFU.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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
| Milestone | Device |
|---|---|
| Started | 101 |
| Completed | 90 |
| Not completed | 11 |
| Withdrew: Death | 7 |
| Withdrew: Lost to follow-up | 4 |
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.
| Participants | Device |
|---|---|
| Number of Participants With Clinical Success: Cessation of Bleeding up to 24 Hours | 100 |
Absence of unanticipated serious adverse device effects within 24 hours.
| Participants | Device |
|---|---|
| Number of Participants Without Device and Procedure-related AEs (Incidence of Device and Procedure-related AEs) | 101 |
Collected over Data collection included endpoints relating to safety and effectiveness during the period from index procedure through 28 days post-procedure.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Device | 7/101 (6.9%) | 12/101 (11.9%) | 3/101 (3%) |
| Event | Device |
|---|---|
| HemorrhageVascular disorders | 2/101 |
| CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/101 |
| Bleeding complicationVascular disorders | 1/101 |
| HematomaSurgical and medical procedures | 1/101 |
| PeritonitisInfections and infestations | 1/101 |
| Hematoma of the left kidneyVascular disorders | 1/101 |
| Progressive deterioration of liver functionHepatobiliary disorders | 1/101 |
| Multi-organ failureGeneral disorders | 1/101 |
| CirrhosisHepatobiliary disorders | 1/101 |
| Ischemic colitisGastrointestinal disorders | 1/101 |
| Event | Device |
|---|---|
| AneurysmVascular disorders | 1/101 |
| Renal failure/renal insufficiencyRenal and urinary disorders | 1/101 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/101 |
| Age, Continuous(years) | Device |
|---|---|
| Mean | 57.1 ± 20.37 |
| Sex: Female, Male(Participants) | Device |
|---|---|
| Female | 47 |
| Male | 54 |
| Ethnicity (NIH/OMB)(Participants) | Device |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 72 |
| Unknown or Not Reported | 25 |
| Race/Ethnicity, Customized(Participants) | Device |
|---|---|
| Race — African American / Black | 2 |
| Race — Asian | 6 |
| Race — Caucasian/ White | 40 |
| Race — Pacific Islander | 5 |
| Race — Other | 23 |
| Race — Not reported / Refuse to disclose | 25 |
| Region of Enrollment(Participants) | Device |
|---|---|
| Australia | 50 |
| France | 51 |
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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