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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04816591
Recruitment Status : Recruiting
First Posted : March 25, 2021
Last Update Posted : February 28, 2024
Sponsor:
Information provided by (Responsible Party):
Cerenovus, Part of DePuy Synthes Products, Inc.

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.

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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


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)




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



Information from the National Library of Medicine

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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

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
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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: February 28, 2024
Last Verified: February 2024
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
Chronic Disease
Disease Attributes