Trials / Completed
CompletedNCT04402632
Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System for Subacute and Chronic Subdural Hematoma
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)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 600 (actual)
- Sponsor
- Medtronic Neurovascular Clinical Affairs · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Surgical Management | Surgical Evacuation of the Subdural Hematoma (SDH) (Control) |
| DEVICE | Onyx™ Liquid Embolic System (LES) Embolization | Onyx™ LES Embolization of the Subdural Hematoma (SDH) |
| OTHER | Observation Only | Medical Management (Control) |
| DEVICE | Onyx™ Liquid Embolic System (LES) Embolization | Onyx™ LES Embolization of the Subdural Hematoma (SDH) |
| PROCEDURE | Surgical Management | Surgical Evacuation of the Subdural Hematoma (SDH) |
Timeline
- Start date
- 2020-10-27
- Primary completion
- 2024-12-19
- Completion
- 2025-04-03
- First posted
- 2020-05-27
- Last updated
- 2025-12-11
Locations
49 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04402632. Inclusion in this directory is not an endorsement.