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SQUID Embolization for Subdural Hematoma (STEM Trial)
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.
STEM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSTEM Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.STEM Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: SQUID
- Group 2: No Embolization
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there still opportunities for people to enroll in this trial?
"According to the info available on clinicaltrials.gov, this research is still open for registration and began accepting participants since November 1st 2020; its details were last updated in November 9th 2022."
How many healthcare facilities are administering this trial?
"This trial is presently enrolling patients from 24 different sites, including those located in New york, Omaha and Tucson. To minimize travel demands it's recommended you select the location nearest to you if participating."
What is the current size of the cohort participating in this evaluation?
"To complete this clinical trial, 310 eligible individuals must enrol. To make the process more convenient for prospective participants, NYU Langone Health in New york City and University of Nebraska in Omaha are two sites offering recruitment."
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