CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 600 enrolled
Drug / intervention
Surgical Management +4 moreprocedure
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/NCT04402632
NCT04402632N/ACompleted
CompareCT.gov

A Study of the Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System In the Treatment of Subacute and Chronic Subdural HEmatoma (EMBOLISE)

Medtronic Neurovascular Clinical Affairs·interventional·Posted May 27, 2020·Updated Dec 11, 2025

In Brief

A clinical study evaluating Surgical Management, Onyx™ Liquid Embolic System (LES) Embolization, and 1 other intervention for Subdural Hematoma. Completed, enrolled 600 participants across 49 sites.

Detailed Summary

The purpose of this study is to evaluate the safety and efficacy of embolization of the middle meningeal artery (MMA) using the Onyx™ Liquid Embolic System (LES) for treatment of symptomatic subacute or chronic subdural hematoma (SDH)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSubdural Hematoma
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMay 27, 2020
Enrollment StartOct 27, 2020
Primary CompletionDec 19, 2024
Study CompletionApr 3, 2025
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 6.1 years ago

Interventions

Surgical Managementprocedure

Surgical Evacuation of the Subdural Hematoma (SDH) (Control)

Onyx™ Liquid Embolic System (LES) Embolizationdevice

Onyx™ LES Embolization of the Subdural Hematoma (SDH)

Observation Onlyother

Medical Management (Control)

Onyx™ Liquid Embolic System (LES) Embolizationdevice

Onyx™ LES Embolization of the Subdural Hematoma (SDH)

Surgical Managementprocedure

Surgical Evacuation of the Subdural Hematoma (SDH)