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Liquid plug could stop bleeding without surgery

NCT ID NCT06742801

Disease control Sponsor: Medtronic Endovascular Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 21, 2026 · Updated 5 times

Summary

This study tests a liquid agent called Onyx™ that is injected into arteries to block active bleeding outside the heart and brain. It includes 119 adults with severe bleeding from trauma, ulcers, or other causes. The goal is to see if it safely stops bleeding without needing further procedures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Onyx™ Liquid Embolic System (a liquid agent injected to block bleeding arteries)
What this could lead to
If successful, this could provide a safe and effective way to stop severe bleeding in trauma or ulcers without surgery.
What could go wrong
This is an early-stage study with only 119 participants. The treatment may fail to stop bleeding or cause unintended blockages. Long-term safety is not yet known.

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 119 people

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

Started

May 2025

Expected to finish

May 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

22 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: 1. Patient is ≥ 22 years old. 2. Active arterial bleeding in the peripheral vasculature confirmed by radiologic and/or endoscopic imaging and deemed suitable for embolization treatment by the investigator. In this study, peripheral vasculature is defined as outside the brain and heart. 3. Patient or legally authorized representative (LAR) is able to provide written consent to participate in the study. 4. Life expectancy of \>30 days, in the opinion of the investigator at the time of enrollment. 5. Target treatment area is free from prior embolization treatment. Exclusion Criteria: 1. Pregnant or breastfeeding. 2. Symptoms of active infection. 3. Patient is known to be participating in the study of an investigational drug, biologic, or device. 4. Contrast allergy or other contraindication to angiography, CT, or catheterization, including contrast sensitivity that cannot be adequately treated prior to index procedure. 5. Known allergy to components of Onyx™. 6. Target vasculature unsuitable for the delivery of Onyx™ based upon physician assessment. 7. More than 4 target lesions will require embolization, in the investigator's opinion after imaging-based assessment.

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Conditions

The condition(s) this trial relates to.

Gastrointestinal Hemorrhage Hemorrhage injury ulcer disease

As listed by the trial registrant

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

Gi bleed Hemorrhage Peripheral arterial hemorrhage Trauma Ulcer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Albany Medical Center

    RECRUITING

    Albany, New York, 12208, United States

  • CHI Health Creighton University Medical Center-Bergan-Mercy

    RECRUITING

    Omaha, Nebraska, 68124, United States

  • Masschusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Rutgers New Jersey Medical School

    RECRUITING

    Newark, New Jersey, 07103, United States

  • Stanford Medical Center

    RECRUITING

    Palo Alto, California, 94304, United States

  • The Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • UCHealth University of Colorado Hospital

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Univ Of Texas Southwestern

    RECRUITING

    Dallas, Texas, 75235, United States

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of California, Irvine

    RECRUITING

    Irvine, California, 92627, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Iowa Hospitals and Clinics

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15237, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37212, United States

  • Yale New Haven

    RECRUITING

    New Haven, Connecticut, 06510, United States

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