Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System for Subacute and Chronic Subdural Hematoma (EMBOLISE)

December 9, 2025 updated by: Medtronic Neurovascular Clinical Affairs

A Study of the Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System In the Treatment of Subacute and Chronic Subdural HEmatoma (EMBOLISE)

The purpose of this study is to evaluate the safety and efficacy of embolization of the middle meningeal artery (MMA) using the Onyx™ Liquid Embolic System (LES) for treatment of symptomatic subacute or chronic subdural hematoma (SDH)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233-1932
        • University of Alabama at Birmingham (UAB) Hospital
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Carondelet St. Joseph's Hospital
    • California
      • Irvine, California, United States, 92868
        • University of California Irvine Medical Center
      • Los Angeles, California, United States, 90033
        • USC - Keck School of Medicine
      • Pasadena, California, United States, 91105
        • Huntington Memorial Hospital
      • San Diego, California, United States, 92037
        • UCSD Medical Center
      • San Francisco, California, United States, 94143
        • University Of California San Francisco Medical Center
      • San Francisco, California, United States, 94109
        • California Pacific Medical Center
      • Torrance, California, United States, 90503-4607
        • Providence Little Company of Mary Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver School of Medicine
    • Florida
      • Gainesville, Florida, United States, 32608
        • UF Health Heart and Vascular Hospital
      • Hollywood, Florida, United States, 33021
        • Memorial Regional Hospital
      • Jacksonville, Florida, United States, 322047
        • Baptist Medical Center Jacksonville
      • Miami, Florida, United States, 33136
        • Jackson Memorial Hospital
      • Orlando, Florida, United States, 32806
        • Orlando Regional Medical Center Orlando Health
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
      • West Palm Beach, Florida, United States, 33407
        • Saint Mary's Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Memorial Hospital
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Park Ridge, Illinois, United States, 60068
        • Advocate Lutheran General Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Ascension Saint Vincent Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • University of Kentucky Albert B Chandler Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Burlington, Massachusetts, United States, 01805-0001
        • Lahey Hospital & Medical Center
    • Michigan
      • Flint, Michigan, United States, 48532
        • McLaren Flint Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Corewell Health
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
      • Buffalo, New York, United States, 14203
        • Buffalo General Medical Center
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10029
        • The Mount Sinai Hospital
      • New York, New York, United States, 10065
        • New York-Presbyterian Hospital/Weill Cornell Medical Center
      • Valhalla, New York, United States, 10595
        • Westchester Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Atrium Health's Carolinas Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195-0001
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43210
        • The Ohio State University/Wexner Medical Center
      • Toledo, Ohio, United States, 43606
        • ProMedica Toledo Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239-3011
        • Oregon Health & Science University Hospital
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Pittsburgh, Pennsylvania, United States, 15213-2536
        • University of Pittsburgh Medical Center UPMC Presbyterian
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Prisma Health
    • Texas
      • Harlingen, Texas, United States, 78550
        • Valley Baptist Medical Center
      • Houston, Texas, United States, 77030
        • Memorial Hermann-Texas Medical Center
      • Temple, Texas, United States, 76508-0001
        • Baylor Scott & White Medical Center - Temple
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Hospital
    • Washington
      • Seattle, Washington, United States, 98104-2420
        • Harborview Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Saint Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pre-morbid Modified Rankin Score ≤3
  • Confirmed diagnosis of subacute or chronic subdural hematoma
  • Completed informed consent
  • Meets criteria for Surgery or Observation Cohort

Exclusion Criteria:

  • Life expectancy <1 year
  • Unable to complete follow-up
  • Pregnant, lactating, or has a positive pregnancy test at time of admission
  • Diagnosed with acute SDH
  • Potentially dangerous anatomic variations leading to increased procedural risk or unsafe access for MMA embolization
  • Pre-randomized Markwalder Grading Scale score ≥ 3
  • Unmanaged, uncontrolled bleeding disorders/blood diathesis
  • Presumed septic embolus, or suspicion of microbial superinfection
  • Known active COVID-19 infection
  • CT or MRI evidence of intra-cranial tumor or mass lesion Contraindication to angiography
  • Participation in another clinical trial
  • Contraindicated for the use of Onyx™ LES
  • Cannot be taken off corticosteroids (intended to treat subacute or chronic SDH) for at least 90 days post-randomization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Surgery Cohort: Control Arm
Procedure: Surgical Management
Surgical Evacuation of the Subdural Hematoma (SDH) (Control)
Procedure: Surgical Management
Surgical Evacuation of the Subdural Hematoma (SDH)
Experimental: Surgery Cohort: Treatment Arm
Procedure: Surgical Management
Surgical Evacuation of the Subdural Hematoma (SDH) (Control)
Procedure: Surgical Management
Surgical Evacuation of the Subdural Hematoma (SDH)
Device: Onyx™ Liquid Embolic System (LES) Embolization
Onyx™ LES Embolization of the Subdural Hematoma (SDH)
Active Comparator: Observational Cohort: Control Arm
Other: Observation Only
Medical Management (Control)
Experimental: Observational Cohort: Treatment Arm
Device: Onyx™ Liquid Embolic System (LES) Embolization
Onyx™ LES Embolization of the Subdural Hematoma (SDH)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Rate of hematoma recurrence/progression requiring surgical drainage OR poor clinical outcome at 90 days, OR clinical deterioration at 90 days compared to baseline
Time Frame: 90 days post-procedure
90 days post-procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Non-inferiority assessment of Onyx™ LES embolization treatment compared to standard of care based on change in Modified Rankin Scale Score
Time Frame: 90 days post-procedure
90 days post-procedure
Effectiveness: Incidence of hospital readmissions
Time Frame: 90 days post-procedure
90 days post-procedure
Effectiveness: Change in hematoma volume based on CT/MRI imaging
Time Frame: 90 days post-procedure
90 days post-procedure
Effectiveness: Change in hematoma thickness per CT/MRI imaging
Time Frame: 90 days post-procedure
90 days post-procedure
Effectiveness: Change in midline shift based on CT/MRI imaging
Time Frame: 90 days post-procedure
90 days post-procedure
Safety: Incidence of device-related serious adverse events
Time Frame: 30 days post-procedure
30 days post-procedure
Safety: Incidence of procedure-related serious adverse events
Time Frame: 30 days post-procedure
30 days post-procedure
Safety: Incidence of neurological death
Time Frame: 90 days and 180 days post-procedure
90 days and 180 days post-procedure
Safety: Incidence of device-related adverse events
Time Frame: 90 days and 180 days post-procedure
90 days and 180 days post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Neurovascular Clinical Affairs

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jared Knopman, MD, New York-Presbyterian Hospital/Weill Cornell Medical Center
  • Principal Investigator: Jason Davies, MD, Buffalo General Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 27, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 19, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 3, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MDT19027ONYX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data will be available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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