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Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA (MEMBRANE)

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ClinicalTrials.gov Identifier: NCT04816591
Recruitment Status : Recruiting
First Posted : March 25, 2021
Last Update Posted : March 22, 2023
Sponsor:
Information provided by (Responsible Party):
Cerenovus, Part of DePuy Synthes Products, Inc.

Study Description
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Brief Summary:
This is a prospective, multi-center, open-label, randomized controlled study in which subjects can receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization for the treatment of chronic subdural hematomas (cSDH).

Condition or disease Intervention/treatment Phase
Chronic Subdural Hematoma Device: Experimental: Interventional Cohort: Treatment Arm Other: Active Comparator: Interventional Cohort: Control Arm Device: Experimental: Observational Cohort: Treatment Arm Other: Active Comparator: Observational Cohort: Control Arm Not Applicable

Detailed Description:
This is a prospective, multi-center, open-label, randomized controlled study in which up to 376 subjects will be randomized to receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization for the treatment of cSDH.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 376 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA
Actual Study Start Date : May 27, 2021
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : May 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental: Interventional Cohort: Treatment Arm
Standard of Care Surgery + Embolization
 Device: Experimental: Interventional Cohort: Treatment Arm
Standard of Care Surgery + Embolization
Active Comparator: Active Comparator: Interventional Cohort: Control Arm
Standard of Care Surgery Only
 Other: Active Comparator: Interventional Cohort: Control Arm
Standard of Care Surgery Only (Control)
Experimental: Experimental: Observational Cohort: Treatment Arm
Standard of Care Medical Management + Embolization
 Device: Experimental: Observational Cohort: Treatment Arm
Standard of Care Medical Management + Embolization
Active Comparator: Active Comparator: Observational Cohort: Control Arm
Medical Management Only
 Other: Active Comparator: Observational Cohort: Control Arm
Standard of Care Medical Management Only (Control)


Outcome Measures
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Primary Outcome Measures :
  1. Effectiveness [ Time Frame: 180 days post procedure ]
    Hematoma recurrence/progression or requiring re-intervention


Secondary Outcome Measures :
  1. Effectiveness [ Time Frame: 180 days post procedure ]
    Reduction of hematoma volume

  2. Safety: Change in mRS [ Time Frame: 180 days post procedure ]
    Change in mRS


Other Outcome Measures:
  1. Health Economics [ Time Frame: 365 days post procedure ]
    Hospital days


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pre-randomization mRS </= 3
  • Confirmed diagnosis of chronic subdural hematoma
  • Completed informed consent

Exclusion Criteria:

  • Acute subdural hematoma
  • Prior treatment of target subdural hematoma
  • Markwalder assessment >/= 3
  • Glasgow Coma Scale < 9
  • Presumed microbial superinfection
  • CT or MRI evidence of intracranial tumor or mass lesion
  • Life expectancy < 1 year
  • Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during the study
  • Current involvement in another clinical trial that may confound study endpoints
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04816591


Contacts
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Contact: Lillian Ma 9494668021 lma46@its.jnj.com

Locations
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United States, New York
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
United States, West Virginia
West Virginia Hospital Recruiting
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Cerenovus, Part of DePuy Synthes Products, Inc.
Investigators
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Principal Investigator: Christopher Kellner, MD MOUNT SINAI HOSPITAL
Principal Investigator: Ansaar Rai, MD West Virginia University
More Information
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Responsible Party: Cerenovus, Part of DePuy Synthes Products, Inc.
ClinicalTrials.gov Identifier: NCT04816591    
Other Study ID Numbers: CNV_2020_01
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: March 22, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
URL: http://yoda.yale.edu.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Cerenovus, Part of DePuy Synthes Products, Inc.:
Chronic Subdural Hematoma, MMA Embolization
Additional relevant MeSH terms:
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Hematoma, Subdural
Hematoma, Subdural, Chronic
Hematoma
Hemorrhage
Pathologic Processes
Intracranial Hemorrhage, Traumatic
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries