Evaluating outcomes of middle meningeal artery embolization for chronic subdural hematoma
Outcomes of Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma; Middle Meningeal Artery Embolization for Chronic Subdural Hematoma (MESH)
This study tests if a new, less invasive treatment called middle meningeal artery embolization can safely help adults with chronic subdural hematoma and reduce the chances of it coming back.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 19 sites (Coral Gables, Florida and 18 other locations) |
| Trial ID | NCT06181994 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the real-world outcomes of chronic subdural hematoma (cSDH) treated with middle meningeal artery embolization (MMAE). It focuses on assessing clinical effectiveness, recurrence rates, and the safety profile of this minimally invasive treatment approach. The study involves a multi-center retrospective cohort design, analyzing data from adult patients who underwent MMAE. The goal is to determine whether this technique offers a favorable alternative to traditional surgical methods.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients aged 18 years or older who have undergone endovascular embolization of the middle meningeal artery.
Not a fit: Patients who have received endovascular embolization using materials other than those specified in the study will not benefit from this research.
Why it matters
Potential benefit: If successful, this study could provide a safer and less invasive treatment option for patients with chronic subdural hematoma.
How similar studies have performed: While the approach of MMA embolization is relatively novel, preliminary studies have suggested promising outcomes, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Consecutive adult patients (18 yrs. of age or older) * Endovascular embolization of middle meningeal artery using any embolization material: PVA particles; Onyx, nBCA glue; dimethyl sulfoxide, microcoils, PVA with microcoils Exclusion Criteria: * Endovascular embolization of middle meningeal artery using any other embolization material
Where this trial is running
Coral Gables, Florida and 18 other locations
- Baptist Health South Florida, Inc. — Coral Gables, Florida, United States (Recruiting)
- Mayo Clinic Florida — Jacksonville, Florida, United States (Completed)
- Orlando Regional Medical Center — Orlando, Florida, United States (Recruiting)
- University of Illinois Chicago — Chicago, Illinois, United States (Completed)
- University of Chicago Medicine — Chicago, Illinois, United States (Recruiting)
- The University of Iowa — Iowa City, Iowa, United States (Completed)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Beth Israel Deaconess Medical Center (BIDMC)/Harvard Medical School — Boston, Massachusetts, United States (Recruiting)
- Lahey Hospital and Medical Center — Burlington, Massachusetts, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Completed)
- Montefiore Medical Center — The Bronx, New York, United States (Recruiting)
- Geisinger Health — Danville, Pennsylvania, United States (Completed)
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
- UTHealth Houston — Houston, Texas, United States (Completed)
- HCA Houston Healthcare Kingwood — Kingwood, Texas, United States (Completed)
- Austin Health — Heidelberg, Victoria, Australia (Recruiting)
- Unity Health Toronto — Toronto, Ontario, Canada (Completed)
- University of Toronto — Toronto, Ontario, Canada (Recruiting)
- Toronto Western Hospital — Toronto, Ontario, Canada (Completed)
Study contacts
- Principal investigator: David Altschul, MD — Montefiore Medical Center
- Study coordinator: Muhammed Amir Essibayi, MD
- Email: muhammedamir.essibayi@einsteinmed.edu
- Phone: 347-908-1889
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.