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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 : Recruiting
First Posted : September 19, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Ronald Benitez, MD, Atlantic Health System

Tracking Information
First Submitted Date  ICMJE September 9, 2019
First Posted Date  ICMJE September 19, 2019
Last Update Posted Date September 19, 2019
Actual Study Start Date  ICMJE June 19, 2019
Estimated Primary Completion Date April 19, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2019)
Change in size of SDH [ Time Frame: 6 months ]
Changes in size of SDH will be recorded in maximum diameter within 6 months.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2019)
Change in Neurological status [ Time Frame: 6 months ]
Changes in Neurological status after the procedure and through study completion
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Middle Meningeal Artery (MMA) Embolization Compared to Traditional Surgical Strategies to Treat Chronic Subdural Hematomas (cSDH)
Official Title  ICMJE 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)
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) embolization compared to traditional surgical strategies for patients presenting with chronic subdural hematoma (cSDH). Although MMA embolization is minimally-invasive procedure that is routinely used for the treatment of tumors or vascular formations (1), this study investigates the use of an established procedure for a new disease state.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Subdural Hematoma
Intervention  ICMJE
  • Procedure: Middle Meningeal Artery procedure
    Seal off the blood supply to the middle meningeal artery to prevent growth of the Subdural Hematoma
  • Procedure: Traditional Surgery
    Drainage of Subdural Hematoma using Craniotomy or Burr Hole
Study Arms  ICMJE
  • Experimental: Middle Meningeal Artery Embolization
    Middle Meningeal Artery Embolization
    Intervention: Procedure: Middle Meningeal Artery procedure
  • Active Comparator: Traditional Surgery
    Craniotomy/Burr hole
    Intervention: Procedure: Traditional Surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 17, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 19, 2022
Estimated Primary Completion Date April 19, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Benitez 973-285-7800 rbenitez@ansdocs.com
Contact: Elena Lobur, RN 908-522-2045 elena.lobur@atlantichealth.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04095819
Other Study ID Numbers  ICMJE AtlanticHS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ronald Benitez, MD, Atlantic Health System
Study Sponsor  ICMJE Atlantic Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Atlantic Health System
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP