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New device aims to stop internal bleeding safely

NCT ID NCT07199348

Disease control Sponsor: Embobio Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests a new medical device called EmboBio to stop bleeding in the abdomen or pelvic area. The device is injected into an artery to block blood flow and control bleeding. The study will include 45 adults in France and will check if the device is safe and works well over about 6 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥18 years * Patient presenting with an arterial abdominopelvic bleeding or risk of bleeding requiring embolization with a permanent embolic agent, i.e. abdominal solid organs hemorrhage including angiomyolipoma, visceral aneurysms and pseudoaneurysms actively bleeding or at risk of bleeding (upper or lower gastrointestinal arteries), pelvic hemorrhage, postpartum hemorrhage in case of active leakage visualized by contrast media extravasation, soft tissue hemorrhage * Patient having provided a written informed consent Exclusion Criteria: * Known hypersensitivity to Agar-Agar * Known hypersensitivity to iodinated contrast media * Patient unable or unwilling to provide a written informed consent * Patient unable to provide informed consent due to his clinical condition * Patient participating in another interventional study * Patient implanted with Embobio device at a previous operating time * Vulnerable, pregnant, and breastfeeding population * Patient unwilling or unable to follow the study schedule * Patients unable to receive prior information on the clinical investigation due to the urgency of the situation * Target arteries diameter \> 2 mm * Vascular anatomy preventing proper placement of the catheter. * Arteriovenous shunts with a high flow rate or a diameter greater than 2 mm

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Conditions

The condition(s) this trial relates to.

Hemorrhage hemorrhagic disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Abdomino-pelvic surgery Bleeding Embolization

Contacts and locations

Locations

  • Hegp-Aphp

    Paris, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.