NCT07291427

Chronic Subdural Hematoma Embolization With Detachable Coils

Safety and Efficacy of Chronic Subdural Hematoma Embolization With Detachable Coils

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, post market registry study designed to evaluate the safety and efficacy of treatment with Balt coils in patients with chronic subdural hematoma (cSDH).

Detailed description

The primary objective of this observational registry study is to assess the safety and efficacy of Balt Coils as an adjunct to middle meningeal artery (MMA) embolization in a real-world setting among patients undergoing treatment for chronic subdural hematoma (cSDH), and explore correlations between patient characteristics, clinical characteristics, and outcomes. By collecting comprehensive, real-world data, the registry will characterize procedural inputs, document clinical and radiographic outcomes, and explore variation in technique and practice setting. The overarching goal is to generate a more complete understanding of Middle Meningeal Artery Embolization (MMAE) in diverse clinical environments, inform future prospective studies, and guide evidence-based adoption of this evolving therapy. Patients may be treated with Balt coils regardless of enrollment in the study as the decision to place the coils should be made independently as per standard of care and prior to enrollment in the study.

Conditions

• Chronic Subdural Hemorrhage (cSDH)

Interventions

Type	Name	Description
DEVICE	Balt coils: (Balt USA, LLC)	MMA embolization utilizing Balt Coils
PROCEDURE	MMA embolization	surgical or bedside evacuation pre or post-surgical debridement

Timeline

• Start date: 2026-07-01
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2025-12-18
• Last updated: 2026-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study