HemorrhageNCT05307783

EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging

An observational study of Hemorrhage and Bleeding Hemorrhage, run by Merit Medical Systems, Inc. at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hemorrhage, Bleeding Hemorrhage
What is being tested?: EmboCube Embolization Gelatin
Type of treatment: Injection or infusion, Medical device
How many people: 101 participants
Where: 5 sitesin 2 countries
Study dates: 30 Nov 2022to 10 Apr 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: 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.

Who may be able to join

Age ≥18 years
Subject requires embolization and is suitable for treatment with EmboCube in accordance with device Instructions For Use for the treatment of bleeding or hemorrhage.
Subject provides written informed consent to study data collection.

Who cannot join

Bleeding site in the neck, head, or brain.
Subject has co-morbidity with survival prognosis of less than 30 days, in the opinion of the treating physician
In the investigator's opinion, participation in the study may not be in the subject's best interest.

Trial locations and contacts

5 sites in 2 countries.

Country

City, postcode or hospital

5 sites in 2 countries

Australia3 sites

Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
South Western Sydney Local Health District
Liverpool
Alfred Health
Sydney

Other trials in Australia

France2 sites

Centre Hospitalier Universitaire de Nîmes - Caremeau
Nîmes
HEGP
Paris

Other trials in France

About this study

Official title: A Multicenter Observational Study to Evaluate Outcomes of EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging

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.

Conditions: Hemorrhage, Bleeding Hemorrhage
Being tested: EmboCube Embolization Gelatin
Medical subject headings: Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EmboCube Embolization GelatinDevice
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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Nov 202210 Apr 2024

First posted1 Apr 2022
Study start30 Nov 2022
Primary completion15 Mar 2024
Study completion10 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HemorrhageStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05307783
Sponsor's protocol ID: EGE-P4-21-01
Status last verified: Jan 2025
First submitted: 23 Mar 2022
Last updated: 22 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated device: Yes

Publications

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.
PubMed 40448890

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter Observational Study to Evaluate Outcomes of EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging
ClinicalTrials.gov ID: NCT05307783
Acronym / sponsor ID: EGE-P4-21-01
Conditions: Hemorrhage, Bleeding Hemorrhage
Study type: Observational
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
Study start: 30 Nov 2022 (actual)
Primary completion: 15 Mar 2024 (actual)
Study completion: 10 Apr 2024 (actual)
First posted: 1 Apr 2022 (actual)
Results: Posted 22 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 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.

Key inclusion criteria (3 listed)

Age ≥18 years
Subject requires embolization and is suitable for treatment with EmboCube in accordance with device Instructions For Use for the treatment of bleeding or hemorrhage.
Subject provides written informed consent to study data collection.

Key exclusion criteria (3 listed)

Bleeding site in the neck, head, or brain.
Subject has co-morbidity with survival prognosis of less than 30 days, in the opinion of the treating physician
In the investigator's opinion, participation in the study may not be in the subject's best interest.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EmboCube Embolization GelatinEmboCube 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	Device	–

Primary outcome

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

Results and safety

Results posted to the registry on 22 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Device	101	90

Primary outcome: Number of Participants With Clinical Success: Cessation of Bleeding up to 24 Hours

Time frame: 24 hours. Count of participants. Unit: Participants

Measure	Device n = 101
Value	100

Primary outcome: Number of Participants Without Device and Procedure-related AEs (Incidence of Device and Procedure-related AEs)

Time frame: 24 hours. Count of participants. Unit: Participants

Measure	Device n = 101
Value	101

Adverse events

Time frame: Data collection included endpoints relating to safety and effectiveness during the period from index procedure through 28 days post-procedure.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Device	12 of 101 (11.9%)	3 of 101 (3%)	7 of 101

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40448890Pellerin 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.

Related trials for Hemorrhage

RecruitingPhase 2
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Immune Thrombocytopenia
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
Active, not recruiting
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Nasal Polyps
RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

5 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hemorrhage and Bleeding Hemorrhage, run by Merit Medical Systems, Inc. at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Clinical Success: Cessation of Bleeding up to 24 Hours (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05307783, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.