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.

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).

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

• Study Type: Interventional (Clinical Trial)
• Actual 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

Arms and Interventions

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

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

• 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

Locations

United States, New York

Mount Sinai Hospital

New York, New York, United States, 10029

United States, West Virginia

West Virginia Hospital

Morgantown, West Virginia, United States, 26506

Sponsors and Collaborators

Cerenovus, Part of DePuy Synthes Products, Inc.

Investigators

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

More Information

• 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
• Last Update Posted: April 24, 2024
• Last Verified: April 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.

• 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:

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