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Embolization Device
SQUID Embolization for Subdural Hematoma (STEM Trial)
N/A
Waitlist Available
Led By Adam Arthur, MD, MPH
Research Sponsored by Balt USA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female Subject whose age is ≥ 30 at the time of consent
cSDH exerts mass effect upon the subjacent brain, as indicated by local cortical flattening or midline shift
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 1-year visit
Awards & highlights
STEM Trial Summary
This trial is designed to see if a new treatment for chronic subdural hematoma (a buildup of blood on the brain) is safe and effective.
Who is the study for?
The STEM trial is for adults aged 30 or older with chronic subdural hematoma (cSDH) that's at least 10 mm thick and causing brain pressure. Participants must have had a stable condition before the cSDH, be experiencing symptoms like headaches or weakness, and commit to follow-up visits. Pregnant women can't join, nor can those who've had certain prior head surgeries or conditions affecting the brain.Check my eligibility
What is being tested?
This study compares different treatments for cSDH: SQUID embolization alone, SQUID plus surgery, standard surgery alone, and medical management without surgery. Patients are randomly assigned to these groups in equal numbers to test safety and effectiveness of MMA embolization with SQUID.See study design
What are the potential side effects?
Possible side effects include discomfort at the catheter insertion site, allergic reactions to contrast dye used during embolization (if not medically managed), bleeding complications from surgical procedures, infection risks post-surgery, and general anesthesia risks.
STEM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 30 years old or older.
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My brain scan shows pressure effects due to a chronic subdural hematoma.
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I have symptoms like headaches, trouble speaking, walking issues, weakness, numbness, or seizures.
STEM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 1-year visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 1-year visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Effectiveness Endpoint
Primary Safety Endpoint
Secondary outcome measures
Any investigational device/procedure-related AE/SAE
Other outcome measures
CT/MRI
Cognitive improvement, as measured by blinded assessment, utilizing the comprehensive neuro-cognitive battery HVLT-R, COWAT, Animal Naming, Trail making tests
EQ-5D-5L (including EQ-VAS)
+5 moreSTEM Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SQUIDExperimental Treatment2 Interventions
Embolization of the Middle Meningeal Artery (MMA)
Group II: No EmbolizationActive Control2 Interventions
Standard Management
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Middle Meningeal Artery (MMA) embolization with SQUID involves blocking the blood flow in the MMA to manage Chronic Subdural Hematoma (cSDH). This treatment works by injecting an embolic agent (SQUID) into the MMA, which causes the artery to become occluded.
This reduces the blood supply to the subdural space, thereby decreasing the formation and expansion of the hematoma. This mechanism is crucial for patients with cSDH as it helps to stabilize the hematoma, prevent further bleeding, and reduce the need for more invasive surgical interventions, ultimately improving patient outcomes and reducing recovery times.
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Who is running the clinical trial?
Balt USALead Sponsor
1 Previous Clinical Trials
600 Total Patients Enrolled
Balt ExtrusionIndustry Sponsor
5 Previous Clinical Trials
10,710 Total Patients Enrolled
Embo-Flüssigkeiten A.G.Industry Sponsor
1 Previous Clinical Trials
111 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had an embolization procedure on my middle meningeal artery.You are expected to live for less than one year.I can provide a negative pregnancy test and will use birth control during the trial.I had surgery for a brain bleed on the same side before.My kidney function is reduced with a creatinine level over 3.0 mg/dL, and I am not on dialysis.I have a brain tumor that is not a subdural hematoma.My brain bleed is located in a specific part of my brain.My surgeon says I need a major or minor brain surgery.Your CT scan shows that at least half of the collection is similar or lighter in color compared to normal brain tissue.My liver is not working well right now.I am 30 years old or older.I can manage or tolerate treatment for my severe allergy to contrast dye.I can visit the trial site for all required follow-ups.My brain scan shows pressure effects due to a chronic subdural hematoma.I have symptoms like headaches, trouble speaking, walking issues, weakness, numbness, or seizures.I need urgent surgery to remove a brain bleed.My chronic subdural hematoma is due to a specific health issue like a brain tumor or after surgery.I have a brain tumor causing pressure or is larger than 1 cm, or I am receiving radiation for head/neck cancer.The thickness of the chronic subdural hematoma (cSDH) is more than 10 millimeters.I understand the study and have signed the consent form.Your ability to function independently was good before this study started.
Research Study Groups:
This trial has the following groups:- Group 1: SQUID
- Group 2: No Embolization
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.
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