Trials / Completed
CompletedNCT04410146
The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 310 (actual)
- Sponsor
- Balt USA · Industry
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
Summary
STEM Study is a pivotal, international, multi-center, prospective, randomized (1:1) controlled trial designed to provide an assessment of the safety and effectiveness of Middle Meningeal Artery (MMA) embolization with SQUID for the management of Chronic Subdural Hematoma (cSDH)
Detailed description
The study objective is to provide an assessment of the safety and effectiveness of Middle Meningeal Artery (MMA) embolization with SQUID for the management of Chronic Subdural Hematoma (cSDH).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SQUID Embolization | Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent |
| DEVICE | SQUID Embolization and Surgical Evacuation | Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent and the surgical evacuation of the sub-dural hematoma |
| PROCEDURE | Surgical Evacuation | Surgical evacuation of the sub-dural hematoma |
| OTHER | Other: Medical Management | Standard |
Timeline
- Start date
- 2020-11-01
- Primary completion
- 2024-05-23
- Completion
- 2024-05-23
- First posted
- 2020-06-01
- Last updated
- 2025-04-30
Locations
32 sites across 4 countries: United States, France, Germany, Spain
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04410146. Inclusion in this directory is not an endorsement.