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

Chronic Subdural Hematoma Clinical Trial

— MEMBRANE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04816591
• Other study ID #: CNV_2020_01
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 27, 2021
• Est. completion date: May 31, 2025

Study information

• Verified date: April 2024
• Source: Cerenovus, Part of DePuy Synthes Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 376
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

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)

Locations

Country	Name	City	State
United States	West Virginia Hospital	Morgantown	West Virginia
United States	Mount Sinai Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Cerenovus, Part of DePuy Synthes Products, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health Economics	Hospital days	365 days post procedure
Primary	Effectiveness	Hematoma recurrence/progression or requiring re-intervention	180 days post procedure
Secondary	Effectiveness	Reduction of hematoma volume	180 days post procedure
Secondary	Safety: Change in mRS	Change in mRS	180 days post procedure