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Liquid Embolic System
Middle Meningeal Artery Embolization for Subdural Hematoma (EMBOLISE Trial)
N/A
Recruiting
Led By Jason Davies, MD
Research Sponsored by Medtronic Neurovascular Clinical Affairs
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pre-morbid Modified Rankin Score ≤3
Confirmed diagnosis of subacute or chronic subdural hematoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days and 180 days post-procedure
Awards & highlights
EMBOLISE Trial Summary
This trial will test whether a new medical treatment, embolization of the middle meningeal artery, is safe and effective for treating people with a type of brain bleed called a subdural hematoma.
Who is the study for?
This trial is for individuals with a confirmed diagnosis of subacute or chronic subdural hematoma, who are relatively independent in daily activities (Modified Rankin Score ≤3), and can consent to treatment. Excluded are those with life expectancy <1 year, severe symptoms (Markwalder score ≥ 3), active COVID-19, pregnancy, acute SDH, uncontrolled bleeding disorders, suspected infections within the brain, unsafe anatomy for the procedure, tumors or mass lesions in the brain, contraindications to angiography or Onyx™ LES use.Check my eligibility
What is being tested?
The study tests if blocking blood flow to the affected area using Onyx™ Liquid Embolic System through embolization of middle meningeal artery is safe and effective for treating symptomatic subacute/chronic subdural hematomas compared to no treatment or standard surgical management.See study design
What are the potential side effects?
Potential side effects may include complications from embolization such as inflammation around the treated area, allergic reactions to materials used like Onyx™ LES during embolization procedure; risks associated with angiography; and general risks related to invasive procedures.
EMBOLISE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was mostly independent in daily activities before my current illness.
Select...
I have been diagnosed with a long-lasting blood clot on the brain.
EMBOLISE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days and 180 days post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days and 180 days post-procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hematoma
Secondary outcome measures
Effectiveness: Change in hematoma thickness per CT/MRI imaging
Effectiveness: Change in hematoma volume based on CT/MRI imaging
Effectiveness: Change in midline shift based on CT/MRI imaging
+6 moreEMBOLISE Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Surgery Cohort: Treatment ArmExperimental Treatment1 Intervention
Treatment
Group II: Observational Cohort: Treatment ArmExperimental Treatment1 Intervention
Treatment
Group III: Surgery Cohort: Control ArmActive Control1 Intervention
Control
Group IV: Observational Cohort: Control ArmActive Control1 Intervention
Control
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treatment
2013
Completed Phase 2
~13740
Find a Location
Who is running the clinical trial?
Medtronic Neurovascular Clinical AffairsLead Sponsor
30 Previous Clinical Trials
8,207 Total Patients Enrolled
Jason Davies, MDPrincipal InvestigatorBuffalo General Medical Center
Jared Knopman, MDPrincipal InvestigatorNew York-Presbyterian Hospital/Weill Cornell Medical Center
1 Previous Clinical Trials
6 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a Markwalder Grading Scale score of 3 or higher before the randomization.I was mostly independent in daily activities before my current illness.I cannot use Onyx™ LES due to health reasons.I must stay on corticosteroids for my SDH for at least 90 days after starting the trial.I am eligible for either surgery or observation.I do not have any uncontrolled bleeding disorders.I currently have an active COVID-19 infection.I might have an infection in my blood or a secondary infection.I have a brain tumor or mass seen on CT or MRI, and cannot undergo angiography.You are not expected to live for more than one year.I have been diagnosed with acute subdural hematoma.I have been diagnosed with a long-lasting blood clot on the brain.You have anatomic variations that could make the procedure risky or unsafe.
Research Study Groups:
This trial has the following groups:- Group 1: Surgery Cohort: Treatment Arm
- Group 2: Surgery Cohort: Control Arm
- Group 3: Observational Cohort: Treatment Arm
- Group 4: Observational Cohort: Control Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is senescence a determining factor for patient enrollment in this trial?
"This medical trial has an upper limit of 90 years and a lower age requirement of 18, thus allowing for the enrolment of adults within this range."
Answered by AI
How widespread is this research endeavor across the state's hospitals?
"Currently, this research is running in 39 sites across the country. These include Pittsburgh, Tucson and Greenville plus 36 other cities. To reduce travel needs if you decide to participate, it's best to identify the local clinic that offers this trial."
Answered by AI
What is the upper limit of participants for this experiment?
"To conduct the trial, 600 patients who match the inclusion criteria must be enrolled. Medtronic Neurovascular Clinical Affairs will coordinate from UPMC Presbyterian in Pittsburgh, Pennsylvania and Carondelet St. Joseph's Hospital in Tucson, Arizona among other designated sites."
Answered by AI
Is this trial actively seeking participants?
"Clinicaltrials.gov reveals that this medical trial is actively recruiting candidates, having been posted on October 27th 2020 and recently updated on September 30th 2022."
Answered by AI
What criteria must one meet to be able to join in this research endeavor?
"Eligibility criteria for this medical trial require that patients have hematoma and are between 18 to 90 years old. The research team is looking for 600 participants in total."
Answered by AI
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