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

Primary Purpose

Subdural Hematoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surgical Management
Surgical Management + Treatment
No Treatment
Treatment
Sponsored by
Medtronic Neurovascular Clinical Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subdural Hematoma

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham (UAB) HospitalRecruiting
  • Carondelet St. Joseph's HospitalRecruiting
  • University of California Irvine Medical CenterRecruiting
  • USC - Keck School of MedicineRecruiting
  • Huntington Memorial HospitalRecruiting
  • UCSD Medical CenterRecruiting
  • Providence Little Company of Mary Medical CenterRecruiting
  • University of Colorado Denver School of MedicineRecruiting
  • UF Health Heart and Vascular HospitalRecruiting
  • Baptist Medical Center JacksonvilleRecruiting
  • Jackson Memorial HospitalRecruiting
  • Orlando Regional Medical Center Orlando HealthRecruiting
  • Tampa General HospitalRecruiting
  • Saint Mary's Medical CenterRecruiting
  • Grady Memorial HospitalRecruiting
  • Rush University Medical CenterRecruiting
  • Advocate Lutheran General HospitalRecruiting
  • Ascension Saint Vincent HospitalRecruiting
  • University of Iowa Hospitals and ClinicsRecruiting
  • University of Kentucky Albert B Chandler HospitalRecruiting
  • Brigham and Women's HospitalRecruiting
  • Lahey Hospital & Medical CenterRecruiting
  • McLaren Flint HospitalRecruiting
  • Spectrum Health HospitalRecruiting
  • Barnes-Jewish HospitalRecruiting
  • Albany Medical CenterRecruiting
  • Buffalo General Medical CenterRecruiting
  • North Shore University HospitalRecruiting
  • The Mount Sinai Hospital
  • New York-Presbyterian Hospital/Weill Cornell Medical CenterRecruiting
  • Westchester Medical CenterRecruiting
  • Atrium Health's Carolinas Medical CenterRecruiting
  • Cleveland ClinicRecruiting
  • The Ohio State University/Wexner Medical CenterRecruiting
  • ProMedica Toledo HospitalRecruiting
  • Oklahoma University Medical Center
  • Oregon Health & Science University HospitalRecruiting
  • Geisinger Medical CenterRecruiting
  • University of Pittsburgh Medical Center UPMC PresbyterianRecruiting
  • Prisma HealthRecruiting
  • Valley Baptist Medical CenterRecruiting
  • Memorial Hermann-Texas Medical CenterRecruiting
  • Baylor Scott & White Medical Center - TempleRecruiting
  • University of Utah HospitalRecruiting
  • Harborview Medical CenterRecruiting
  • Aurora Saint Luke's Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Surgery Cohort: Control Arm

Surgery Cohort: Treatment Arm

Observational Cohort: Control Arm

Observational Cohort: Treatment Arm

Arm Description

Control

Treatment

Control

Treatment

Outcomes

Primary Outcome Measures

Effectiveness: Incidence of hematoma recurrence/progression requiring re-intervention

Secondary Outcome Measures

Non-inferiority assessment of Onyx™ LES embolization treatment compared to standard of care based on change in Modified Rankin Scale Score
Effectiveness: Incidence of hospital readmissions
Effectiveness: Change in hematoma volume based on CT/MRI imaging
Effectiveness: Change in hematoma thickness per CT/MRI imaging
Effectiveness: Change in midline shift based on CT/MRI imaging
Safety: Incidence of device-related serious adverse events
Safety: Incidence of procedure-related serious adverse events
Safety: Incidence of neurological death
Safety: Incidence of device-related adverse events

Full Information

First Posted
May 18, 2020
Last Updated
October 17, 2023
Sponsor
Medtronic Neurovascular Clinical Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT04402632
Brief Title
Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System for Subacute and Chronic Subdural Hematoma
Acronym
EMBOLISE
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 27, 2020 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Neurovascular Clinical Affairs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief Summary
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subdural Hematoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgery Cohort: Control Arm
Arm Type
Active Comparator
Arm Description
Control
Arm Title
Surgery Cohort: Treatment Arm
Arm Type
Experimental
Arm Description
Treatment
Arm Title
Observational Cohort: Control Arm
Arm Type
Active Comparator
Arm Description
Control
Arm Title
Observational Cohort: Treatment Arm
Arm Type
Experimental
Arm Description
Treatment
Intervention Type
Procedure
Intervention Name(s)
Surgical Management
Intervention Description
SDH Evacuation (Control)
Intervention Type
Device
Intervention Name(s)
Surgical Management + Treatment
Intervention Description
SDH Evacuation + Onyx™ LES Embolization
Intervention Type
Other
Intervention Name(s)
No Treatment
Intervention Description
Observation Only (Control)
Intervention Type
Device
Intervention Name(s)
Treatment
Intervention Description
Onyx™ LES Embolization
Primary Outcome Measure Information:
Title
Effectiveness: Incidence of hematoma recurrence/progression requiring re-intervention
Time Frame
90 days post-procedure
Secondary Outcome Measure Information:
Title
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
Title
Effectiveness: Incidence of hospital readmissions
Time Frame
90 days post-procedure
Title
Effectiveness: Change in hematoma volume based on CT/MRI imaging
Time Frame
90 days post-procedure
Title
Effectiveness: Change in hematoma thickness per CT/MRI imaging
Time Frame
90 days post-procedure
Title
Effectiveness: Change in midline shift based on CT/MRI imaging
Time Frame
90 days post-procedure
Title
Safety: Incidence of device-related serious adverse events
Time Frame
30 days post-procedure
Title
Safety: Incidence of procedure-related serious adverse events
Time Frame
30 days post-procedure
Title
Safety: Incidence of neurological death
Time Frame
90 days and 180 days post-procedure
Title
Safety: Incidence of device-related adverse events
Time Frame
90 days and 180 days post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medtronic Neurovascular Clinical Affairs
Phone
1(949) 837-3700
Email
rs.embolisestudy@medtronic.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jared Knopman, MD
Organizational Affiliation
New York-Presbyterian Hospital/Weill Cornell Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jason Davies, MD
Organizational Affiliation
Buffalo General Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham (UAB) Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233-1932
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesse Jones, MD
Facility Name
Carondelet St. Joseph's Hospital
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Coon, MD
Facility Name
University of California Irvine Medical Center
City
Irvine
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuichi Suzuki, MD
Facility Name
USC - Keck School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Mack, MD
Facility Name
Huntington Memorial Hospital
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Ross, MD
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Pannell, MD
Facility Name
Providence Little Company of Mary Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90503-4607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Tarpley, MD
Facility Name
University of Colorado Denver School of Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Roark, MD
Facility Name
UF Health Heart and Vascular Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Koch, MD
Facility Name
Baptist Medical Center Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
322047
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo Hanel, MD
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Starke, MD
Facility Name
Orlando Regional Medical Center Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marshall Cress, MD
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxim Mokin, MD
Facility Name
Saint Mary's Medical Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Malek, MD
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Grossberg, MD
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Webster Crowley, MD
Facility Name
Advocate Lutheran General Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Billingsley, MD
Facility Name
Ascension Saint Vincent Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Sahlein, MD
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Dlouhy, MD
Facility Name
University of Kentucky Albert B Chandler Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Fraser, MD
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Aziz-Sultan, MD
Facility Name
Lahey Hospital & Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805-0001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neil Patel, MD
Facility Name
McLaren Flint Hospital
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aniel Majjhoo, MD
Facility Name
Spectrum Health Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Singer, MD
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Osbun, MD
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Paul, MD
Facility Name
Buffalo General Medical Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Davies, MD
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Link, MD
Facility Name
The Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
New York-Presbyterian Hospital/Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jared Knopman, MD
Facility Name
Westchester Medical Center
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Santarelli, MD
Facility Name
Atrium Health's Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joe Bernard, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-0001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Bain, MD
Facility Name
The Ohio State University/Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Youssef, MD
Facility Name
ProMedica Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mouhammad Jumaa, MD
Facility Name
Oklahoma University Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Oregon Health & Science University Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesse Liu, MD
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clemens Schirmer, MD
Facility Name
University of Pittsburgh Medical Center UPMC Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-2536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bradley Gross, MD
Facility Name
Prisma Health
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Chaudry, MD
Facility Name
Valley Baptist Medical Center
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ameer Hassan, MD
Facility Name
Memorial Hermann-Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Chen, MD
Facility Name
Baylor Scott & White Medical Center - Temple
City
Temple
State/Province
Texas
ZIP/Postal Code
76508-0001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walter Lesley, MD
Facility Name
University of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramesh Grandhi, MD
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104-2420
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Levitt, MD
Facility Name
Aurora Saint Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Wolfe, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be available

Learn more about this trial

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

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