Back to resultsMiddle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA (MEMBRANE)
Primary Purpose
Chronic Subdural Hematoma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental: Interventional Cohort: Treatment Arm
Active Comparator: Interventional Cohort: Control Arm
Experimental: Observational Cohort: Treatment Arm
Active Comparator: Observational Cohort: Control Arm
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Subdural Hematoma focused on measuring Chronic Subdural Hematoma, MMA Embolization
Eligibility 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
Sites / Locations
- Mount Sinai HospitalRecruiting
- West Virginia HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Experimental: Interventional Cohort: Treatment Arm
Active Comparator: Interventional Cohort: Control Arm
Experimental: Observational Cohort: Treatment Arm
Active Comparator: Observational Cohort: Control Arm
Arm Description
Standard of Care Surgery + Embolization
Standard of Care Surgery Only
Standard of Care Medical Management + Embolization
Medical Management Only
Outcomes
Primary Outcome Measures
Effectiveness
Hematoma recurrence/progression or requiring re-intervention
Secondary Outcome Measures
Effectiveness
Reduction of hematoma volume
Safety: Change in mRS
Change in mRS
Full Information
NCT ID
NCT04816591
First Posted
March 23, 2021
Last Updated
October 10, 2023
Sponsor
Cerenovus, Part of DePuy Synthes Products, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04816591
Brief Title
Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA
Acronym
MEMBRANE
Official Title
Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 27, 2021 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cerenovus, Part of DePuy Synthes Products, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Subdural Hematoma
Keywords
Chronic Subdural Hematoma, MMA Embolization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
376 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Interventional Cohort: Treatment Arm
Arm Type
Experimental
Arm Description
Standard of Care Surgery + Embolization
Arm Title
Active Comparator: Interventional Cohort: Control Arm
Arm Type
Active Comparator
Arm Description
Standard of Care Surgery Only
Arm Title
Experimental: Observational Cohort: Treatment Arm
Arm Type
Experimental
Arm Description
Standard of Care Medical Management + Embolization
Arm Title
Active Comparator: Observational Cohort: Control Arm
Arm Type
Active Comparator
Arm Description
Medical Management Only
Intervention Type
Device
Intervention Name(s)
Experimental: Interventional Cohort: Treatment Arm
Intervention Description
Standard of Care Surgery + Embolization
Intervention Type
Other
Intervention Name(s)
Active Comparator: Interventional Cohort: Control Arm
Intervention Description
Standard of Care Surgery Only (Control)
Intervention Type
Device
Intervention Name(s)
Experimental: Observational Cohort: Treatment Arm
Intervention Description
Standard of Care Medical Management + Embolization
Intervention Type
Other
Intervention Name(s)
Active Comparator: Observational Cohort: Control Arm
Intervention Description
Standard of Care Medical Management Only (Control)
Primary Outcome Measure Information:
Title
Effectiveness
Description
Hematoma recurrence/progression or requiring re-intervention
Time Frame
180 days post procedure
Secondary Outcome Measure Information:
Title
Effectiveness
Description
Reduction of hematoma volume
Time Frame
180 days post procedure
Title
Safety: Change in mRS
Description
Change in mRS
Time Frame
180 days post procedure
Other Pre-specified Outcome Measures:
Title
Health Economics
Description
Hospital days
Time Frame
365 days post procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lillian Ma
Phone
9494668021
Email
lma46@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Kellner, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ansaar Rai, MD
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
West Virginia Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
http://yoda.yale.edu.
Learn more about this trial
Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA
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