Recruiting

MMA vs. Surgical Strategies

Sponsor:

Atlantic Health System

Code:

NCT04095819

Conditions

Chronic Subdural Hematoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Middle Meningeal Artery procedure

Traditional Surgery

Study Details

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.

Conditions

Chronic Subdural Hematoma

Study ID

NCT04095819

Start date

Jun 19, 2019

Status verified date

Sep, 2019

Completion date

Apr 19, 2022

Anticipated

Primary completion date

Apr 19, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Middle Meningeal Artery Embolization

Middle Meningeal Artery Embolization

active comparator: Traditional Surgery

Craniotomy/Burr hole

Interventions

Middle Meningeal Artery procedure

Seal off the blood supply to the middle meningeal artery to prevent growth of the Subdural Hematoma

Traditional Surgery

Drainage of Subdural Hematoma using Craniotomy or Burr Hole

Primary outcome measure

  • Change in size of SDH [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Benitez

973-285-7800rbenitez@ansdocs.com

Elena Lobur, RN

908-522-2045elena.lobur@atlantichealth.org

Locations

Overlook Medical Center

Recruiting

Summit, New Jersey, United States, 07901

Contacts

Ron Benitez, MD

973-285-7800rebenitez@ansdocs.com

Elena Lobur, RN

908-522-2045elena.lobur@atlantichealth.org

More Information

Sponsor

Atlantic Health System

Last update posted

Sep 19, 2019

Last verified

Sep, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Atlantic Health System on 2019-09-19.