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

Cerenovus

Status: Active, not recruiting

Conditions: Chronic Subdural Hematoma

Treatments: Other: Active Comparator: Interventional Cohort: Control Arm; Other: Active Comparator: Observational Cohort: Control Arm; Device: Experimental: Observational Cohort: Treatment Arm; Device: Experimental: Interventional Cohort: Treatment Arm

Study type: Interventional

Funder types: Industry

Identifiers

NCT04816591

CNV_2020_01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 376 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

376 participants in 4 patient groups

Experimental: Interventional Cohort: Treatment Arm

Experimental group

Description:

Standard of Care Surgery + Embolization

Treatment:

Device: Experimental: Interventional Cohort: Treatment Arm

Active Comparator: Interventional Cohort: Control Arm

Active Comparator group

Description:

Standard of Care Surgery Only

Treatment:

Other: Active Comparator: Interventional Cohort: Control Arm

Experimental: Observational Cohort: Treatment Arm

Experimental group

Description:

Standard of Care Medical Management + Embolization

Treatment:

Device: Experimental: Observational Cohort: Treatment Arm

Active Comparator: Observational Cohort: Control Arm

Active Comparator group

Description:

Medical Management Only

Treatment:

Other: Active Comparator: Observational Cohort: Control Arm