NCT04816591

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 376 (actual)
• Sponsor: Cerenovus, Part of DePuy Synthes Products, Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Subdural Hematoma

Interventions

Type	Name	Description
DEVICE	Experimental: Interventional Cohort: TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System	Standard of Care Surgery + Embolization
OTHER	Standard of Care Surgery	Standard of Care Surgery Only
DEVICE	Experimental: Interventional Cohort: TRUFILL n-BCA Liquid Embolic System	Standard of Care Medical Management + Embolization
OTHER	Standard of Care Medical Management	Standard of Care Medical Management Only

Timeline

• Start date: 2021-05-27
• Primary completion: 2024-08-15
• Completion: 2025-03-26
• First posted: 2021-03-25
• Last updated: 2026-03-13
• Results posted: 2026-02-24

Locations

33 sites across 2 countries: United States, China

Regulatory

• FDA-regulated device study