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

NCT04816591 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 376

Last updated 2026-05-12

Study results available
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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).

Conditions

  • Chronic Subdural Hematoma

Interventions

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

Sponsors & Collaborators

  • Cerenovus, Part of DePuy Synthes Products, Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher Kellner, MD · MOUNT SINAI HOSPITAL

  • Ansaar Rai, MD · West Virginia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-27
Primary Completion
2024-08-15
Completion
2025-03-26
FDA Device
Yes

Countries

  • United States
  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04816591 on ClinicalTrials.gov