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

• ClinicalTrials.gov Identifier: NCT04816591
• Recruitment Status: Active, not recruiting
• First Posted: March 25, 2021
• Last Update Posted: April 24, 2024
• Sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.
• Information provided by (Responsible Party): Cerenovus, Part of DePuy Synthes Products, Inc.

Tracking Information

• First Submitted Date: March 23, 2021
• First Posted Date: March 25, 2021
• Last Update Posted Date: April 24, 2024
• Actual Study Start Date: May 27, 2021
• Estimated Primary Completion Date: May 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 23, 2021)

Effectiveness [ Time Frame: 180 days post procedure ]

Hematoma recurrence/progression or requiring re-intervention

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 23, 2021)

• Effectiveness [ Time Frame: 180 days post procedure ]
  Reduction of hematoma volume
• Safety: Change in mRS [ Time Frame: 180 days post procedure ]
  Change in mRS

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: March 23, 2021)

Health Economics [ Time Frame: 365 days post procedure ]

Hospital days

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA
• Official Title: Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Chronic Subdural Hematoma

Intervention

• Device: Experimental: Interventional Cohort: Treatment Arm
  Standard of Care Surgery + Embolization
• Other: Active Comparator: Interventional Cohort: Control Arm
  Standard of Care Surgery Only (Control)
• Device: Experimental: Observational Cohort: Treatment Arm
  Standard of Care Medical Management + Embolization
• Other: Active Comparator: Observational Cohort: Control Arm
  Standard of Care Medical Management Only (Control)

Study Arms

• Experimental: Experimental: Interventional Cohort: Treatment Arm
  Standard of Care Surgery + Embolization
  Intervention: Device: Experimental: Interventional Cohort: Treatment Arm
• Active Comparator: Active Comparator: Interventional Cohort: Control Arm
  Standard of Care Surgery Only
  Intervention: Other: Active Comparator: Interventional Cohort: Control Arm
• Experimental: Experimental: Observational Cohort: Treatment Arm
  Standard of Care Medical Management + Embolization
  Intervention: Device: Experimental: Observational Cohort: Treatment Arm
• Active Comparator: Active Comparator: Observational Cohort: Control Arm
  Medical Management Only
  Intervention: Other: Active Comparator: Observational Cohort: Control Arm

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: March 23, 2021): 376
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 31, 2025
• Estimated Primary Completion Date: May 31, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04816591
• Other Study ID Numbers: CNV_2020_01
• 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: Yes

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.

• Current Responsible Party: Cerenovus, Part of DePuy Synthes Products, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Christopher Kellner, MD; MOUNT SINAI HOSPITAL
• Principal Investigator: Ansaar Rai, MD; West Virginia University

• PRS Account: Cerenovus, Part of DePuy Synthes Products, Inc.
• Verification Date: April 2024