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

• Sponsor: Cerenovus, Part of DePuy Synthes Products, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04816591
• Collaborator: (none)
• Enrollment: 376
• Locations: 2
• Arms: 4
• Anticipated Duration (Months): 48.1
• Patients Per Site: 188
• Patients Per Site Per Month: 3.9

Study Details

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	N/A

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
• Anticipated 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
• Anticipated Primary Completion Date: May 31, 2024
• Anticipated 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 [180 days post procedure]

   Hematoma recurrence/progression or requiring re-intervention

Secondary Outcome Measures

1. Effectiveness [180 days post procedure]

   Reduction of hematoma volume

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

   Change in mRS

Other Outcome Measures

1. Health Economics [365 days post procedure]

   Hospital days

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	Mount Sinai Hospital	New York	New York	United States	10029
2	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cerenovus, Part of DePuy Synthes Products, Inc.
• ClinicalTrials.gov Identifier: NCT04816591
• Other Study ID Numbers: CNV_2020_01
• First Posted: Mar 25, 2021
• Last Update Posted: Aug 9, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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

Study Results

No Results Posted as of Aug 9, 2022