- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04095819
Middle Meningeal Artery (MMA) Embolization Compared to Traditional Surgical Strategies to Treat Chronic Subdural Hematomas (cSDH)
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)
Study Overview
Status
Conditions
Intervention / Treatment
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 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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Benitez
- Phone Number: 973-285-7800
- Email: rbenitez@ansdocs.com
Study Contact Backup
- Name: Elena Lobur, RN
- Phone Number: 908-522-2045
- Email: elena.lobur@atlantichealth.org
Study Locations
-
-
New Jersey
-
Summit, New Jersey, United States, 07901
- Recruiting
- Overlook Medical Center
-
Contact:
- Elena Lobur, RN
- Phone Number: 908-522-2045
- Email: elena.lobur@atlantichealth.org
-
Contact:
- Ron Benitez, MD
- Phone Number: 973-285-7800
- Email: rebenitez@ansdocs.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Middle Meningeal Artery Embolization
|
Seal off the blood supply to the middle meningeal artery to prevent growth of the Subdural Hematoma
|
Active Comparator: Traditional Surgery
Craniotomy/Burr hole
|
Drainage of Subdural Hematoma using Craniotomy or Burr Hole
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in size of SDH
Time Frame: 6 months
|
Changes in size of SDH will be recorded in maximum diameter within 6 months.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Neurological status
Time Frame: 6 months
|
Changes in Neurological status after the procedure and through study completion
|
6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Hemorrhage
- Craniocerebral Trauma
- Trauma, Nervous System
- Intracranial Hemorrhages
- Intracranial Hemorrhage, Traumatic
- Hematoma
- Hematoma, Subdural
- Hematoma, Subdural, Chronic
Other Study ID Numbers
- AtlanticHS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Subdural Hematoma
-
Ataturk Training and Research HospitalCompletedSubdural Hematoma, ChronicTurkey
-
Ospedale Policlinico San MartinoNot yet recruitingEndovascular vs Conservative Treatment in Patients With Chronic Subdural Hematomas and Mild SymptomsSubdural Hematoma, Chronic
-
University Hospital, MontpellierHospices Civils de Lyon; Centre Hospitalier Universitaire de Nice; University... and other collaboratorsTerminatedChronic Intracranial Subdural HematomaFrance
-
Balt USAAXIOM Real Time Metrics; Embo-Flüssigkeiten A.G.; Balt ExtrusionActive, not recruitingSubdural Hematoma, ChronicUnited States, France, Germany, Spain
-
Rennes University HospitalCompleted
-
Academisch Medisch Centrum - Universiteit van Amsterdam...RecruitingChronic Subdural HematomasNetherlands
-
Chinese University of Hong KongWithdrawnChronic Subdural Hematoma | Subdural HematomaChina
-
The University of Texas Medical Branch, GalvestonNational Institute of Neurological Disorders and Stroke (NINDS)Not yet recruitingChronic Subdural HematomaUnited States
-
University Hospital, GenevaNot yet recruitingChronic Subdural Hematomas | Cerebral Compression Due to Injury
-
Kwong Wah HospitalUnknownChronic Subdural Hematoma | Subdural DrainChina
Clinical Trials on Middle Meningeal Artery procedure
-
Zeguang RenRecruiting
-
Ospedale Policlinico San MartinoNot yet recruitingEndovascular vs Conservative Treatment in Patients With Chronic Subdural Hematomas and Mild SymptomsSubdural Hematoma, Chronic
-
University of ManitobaRecruitingSubdural HematomaCanada
-
University Hospital, MontpellierRecruitingBrain Diseases | Central Nervous System Diseases | Wounds and Injuries | Hematoma, Subdural, ChronicFrance
-
The University of Texas Medical Branch, GalvestonNational Institute of Neurological Disorders and Stroke (NINDS)Not yet recruitingChronic Subdural HematomaUnited States
-
Chinese University of Hong KongWithdrawnChronic Subdural Hematoma | Subdural HematomaChina
-
Dartmouth-Hitchcock Medical CenterCompletedChronic Subdural Hematoma | Subdural HematomaUnited States
-
Region SkaneKarolinska University Hospital; Lund University; Sahlgrenska University Hospital... and other collaboratorsRecruitingChronic Subdural HematomaSweden
-
University of ManitobaRecruitingChronic Subdural HematomaCanada
-
Academisch Medisch Centrum - Universiteit van Amsterdam...RecruitingChronic Subdural HematomasNetherlands