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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EmboCube Embolization Gelatin | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chris O'Brien Lifehouse | Camperdown | New South Wales | 2050 | Australia | ||
| South Western Sydney Local Health District |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40448890 | Derived | Pellerin O, Frandon J, Schlaphoff G, Copping R, Dean C, Clements W. A multicenter prospective study evaluating use of EmboCube Embolization Gelatin alone or in combination with other embolic agents to control bleeding. CVIR Endovasc. 2025 May 31;8(1):50. doi: 10.1186/s42155-025-00571-w. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Device | Treated with EmboCube Embolization Gelatin |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Device | Treated with EmboCube Embolization Gelatin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 24 hours |
|
|
Data collection included endpoints relating to safety and effectiveness during the period from index procedure through 28 days post-procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Device | Treated with EmboCube Embolization Gelatin | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding complication | Vascular disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aneurysm | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vicky Brunk | Merit Medical | (385) 766-9152 | vicky.brunk@merit.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 30, 2022 | Nov 27, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 13, 2022 | Sep 10, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Liverpool |
| Australia |
| Alfred Health | Sydney | Australia |
| Centre Hospitalier Universitaire de Nîmes - Caremeau | Nîmes | France |
| HEGP | Paris | France |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | 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. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| 101 |
| 12 |
| 101 |
| 3 |
| 101 |
| Hematoma | Surgical and medical procedures | Non-systematic Assessment |
|
| Hemorrhage | Vascular disorders | Non-systematic Assessment |
|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Peritonitis | Infections and infestations | Non-systematic Assessment |
|
| Hematoma of the left kidney | Vascular disorders | Non-systematic Assessment |
|
| Progressive deterioration of liver function | Hepatobiliary disorders | Non-systematic Assessment |
|
| Multi-organ failure | General disorders | Non-systematic Assessment |
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| Cirrhosis | Hepatobiliary disorders | Non-systematic Assessment |
|
| Ischemic colitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Renal failure/renal insufficiency | Renal and urinary disorders | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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