CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 376 enrolled / 376 target
Drug / intervention
Experimental: Interventional Cohort: TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04816591
NCT04816591N/ACompletedMonitor (6.2/mo)Completion was 22mo ago

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

Cerenovus, Part of DePuy Synthes Products, Inc.·interventional·Posted Mar 25, 2021·Updated Jun 5, 2026

In Brief

A clinical study evaluating Experimental: Interventional Cohort: TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System, Standard of Care Surgery, and 2 other interventions for Chronic Subdural Hematoma. Completed, enrolled 376 participants across 33 sites in 2 countries.

Signals

Enrolling slower than its timeline implies

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina, United States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 25, 2021
Enrollment StartMay 27, 2021
Primary CompletionAug 15, 2024
Study CompletionMar 26, 2025
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 5.3 years ago

Arms & Interventions

Experimental: Interventional Cohort: Treatment Armexperimental

Standard of Care Surgery + Embolization

Device: Experimental: Interventional Cohort: TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
Standard of Care Surgery Onlyactive_comparator

Standard of Care Surgery Only

Other: Standard of Care Surgery
Interventional Cohort: Treatment Armexperimental

Standard of Care Medical Management + Embolization

Device: Experimental: Interventional Cohort: TRUFILL n-BCA Liquid Embolic System
Standard of Care Medical Management Onlyactive_comparator

Standard of Care medical management only.

Other: Standard of Care Medical Management

Interventions

Experimental: Interventional Cohort: TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic Systemdevice

Standard of Care Surgery + Embolization

Standard of Care Surgeryother

Standard of Care Surgery Only

Experimental: Interventional Cohort: TRUFILL n-BCA Liquid Embolic Systemdevice

Standard of Care Medical Management + Embolization

Standard of Care Medical Managementother

Standard of Care Medical Management Only