Middle Meningeal Artery (MMA) Embolization Compared to Traditional Surgical Strategies to Treat Chronic Subdural Hematomas (cSDH)
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|ClinicalTrials.gov Identifier: NCT04095819|
Recruitment Status : Unknown
Verified September 2019 by Ronald Benitez, MD, Atlantic Health System.
Recruitment status was: Recruiting
First Posted : September 19, 2019
Last Update Posted : September 19, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Chronic Subdural Hematoma||Procedure: Middle Meningeal Artery procedure Procedure: Traditional Surgery||Not Applicable|
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 the brain's surface beneath the skull. Subdural hematomas can be life-threatening. They usually result from a head injury. This study will compare the new procedure to conventional surgical treatment of chronic subdural hematoma (cSDH). The new procedure is called middle meningeal artery embolization (MMA).
Current or conventional treatment of chronic subdural hematoma (cSDH) involves surgery (burr hole drainage and craniotomy) to access and remove the cause of the bleeding that is causing the subdural hematoma.
The new procedure, MMA embolization, involves guiding a catheter that is inserted into a blood vessel to the area of the brain that is supplying blood to the subdural hematoma. Particles or a special type of glue will be released to stop the bleeding that is causing the subdural hematoma. This technique has been used to treat other brain conditions, for example, (to treat tumors or malformation of blood vessels).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study to Evaluate Safety of and Efficacy of Middle Meningeal Artery (MMA) Embolization Compared to Traditional Surgical Strategies to Treat Chronic Subdural Hematomas (cSDH)|
|Actual Study Start Date :||June 19, 2019|
|Estimated Primary Completion Date :||April 19, 2022|
|Estimated Study Completion Date :||April 19, 2022|
Experimental: Middle Meningeal Artery Embolization
Middle Meningeal Artery Embolization
Procedure: Middle Meningeal Artery procedure
Seal off the blood supply to the middle meningeal artery to prevent growth of the Subdural Hematoma
Active Comparator: Traditional Surgery
Procedure: Traditional Surgery
Drainage of Subdural Hematoma using Craniotomy or Burr Hole
- Change in size of SDH [ Time Frame: 6 months ]Changes in size of SDH will be recorded in maximum diameter within 6 months.
- Change in Neurological status [ Time Frame: 6 months ]Changes in Neurological status after the procedure and through study completion
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04095819
|Contact: Elena Lobur, RNemail@example.com|
|United States, New Jersey|
|Overlook Medical Center||Recruiting|
|Summit, New Jersey, United States, 07901|
|Contact: Ron Benitez, MD 973-285-7800 firstname.lastname@example.org|
|Contact: Elena Lobur, RN 908-522-2045 email@example.com|
|Responsible Party:||Ronald Benitez, MD, Director of Endovascular Surgery, Atlantic Health System|
|Other Study ID Numbers:||
|First Posted:||September 19, 2019 Key Record Dates|
|Last Update Posted:||September 19, 2019|
|Last Verified:||September 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Hematoma, Subdural, Chronic
Intracranial Hemorrhage, Traumatic
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries