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MMA Embolization With NeoCast for Subacute and Chronic Subdural Hematoma

NCT07541404 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2026-05-20

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of embolization of the middle meningeal artery (MMA) using the NeoCast Embolic System for treatment of symptomatic subacute or chronic subdural hematoma (SDH) adjunctive to surgery.

Conditions

  • Subdural Hematoma

Interventions

DEVICE

NeoCast Embolic System

NeoCast will be used to embolize a participant's middle meningeal artery in an endovascular procedure before or after adjunctive surgery to drain the hematoma

DEVICE

Onyx LES, an FDA-Approved Commercial Liquid Embolic

Onyx LES, an FDA-approved commercial liquid embolic, will be used to embolize a participant's middle meningeal artery in an endovascular procedure before or after adjunctive surgery to drain the hematoma

Sponsors & Collaborators

  • Arsenal Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Charles Matouk, MD · Yale Neurosciences Institute

  • Michael Levitt, MD · University of Washington Medicine - Harborview Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-01-31
Completion
2028-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07541404 on ClinicalTrials.gov