Status:
UNKNOWN
Middle Meningeal Artery (MMA) Embolization Compared to Traditional Surgical Strategies to Treat Chronic Subdural Hematomas (cSDH)
Lead Sponsor:
Atlantic Health System
Conditions:
Chronic Subdural Hematoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Chronic Subdural Hematoma (cSDH) is a common hematologic problem particularly in older patients. The purpose of this study is to evaluate the safety and efficacy of middle meningeal artery (MMA) embol...
Detailed Description
The purpose of the research study is to evaluate the safety and efficacy of a new, less-invasive procedure to treat chronic subdural hematoma (cSDH). A subdural hematoma occurs when blood collects on ...
Eligibility Criteria
Inclusion
- Age 18 or older
- Participant or Surrogate must be English speaking
- Subjects must have a diagnosis of chronic or acute-on subdural hematoma based on brain imaging, as documented by an
- One or more symptoms attributable to chronic SDH including headache cognitive impairment, gait instability, seizure, or mild focal neurologic deficit.
- In opinion of Investigator or the subject's referring physician, the subject has failed conservative management.
Exclusion
- The Subdural hematoma is causing mass effect significant enough to cause marked or progressive neurologic impairment
- Any requirement for urgent surgical evacuation is necessary
- Life expectancy is less than 6 months in the opinion of the subject's primary physician
- Markedly tortuous vasculature precluding safe endovascular access, as assessed on angiogram
- Acute subdural hematomas
- Health insurance doesn't cover MMA embolization or performing Surgeon and follow up visits are considered out of network.
- Pregnancy
Key Trial Info
Start Date :
June 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 19 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04095819
Start Date
June 19 2019
End Date
April 19 2022
Last Update
September 19 2019
Active Locations (1)
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1
Overlook Medical Center
Summit, New Jersey, United States, 07901