MMA Embolization With NeoCast for Subacute and Chronic Subdural Hematoma

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Arsenal Medical, Inc.
Study ID
NCT07541404
Status
Not Yet Recruiting

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Conditions

  • Subdural Hematoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • NeoCast Embolic System — DEVICE
    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
  • Onyx LES, an FDA-Approved Commercial Liquid Embolic — DEVICE
    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

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Jan 31, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NeoCast Embolic System
    Participants randomized to the NeoCast arm will have their MMA embolized with NeoCast adjunctive to surgery
  • Active Comparator: Onyx LES FDA-Approved Commercial Liquid Embolic
    Participants randomized to the active comparator control arm will have their MMA embolized with Onyx LES, an FDA-approved commercial liquid embolic adjunctive to surgery

Primary Outcome Measure

Comparison of NeoCast arm vs. Onyx LES arm for a composite endpoint of treatment failure events [ Time Frame: 90 Days post-treatment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Yale Neurosciences InstituteNew HavenConnecticut06519-
University of Washington Medicine - Harborview Medical CenterSeattleWashington98104-

Find similar trials in New Haven, CT

By research site
Yale Neurosciences Institute· New Haven, CTUniversity of Washington Medicine - Harborview Medical Center· Seattle, WA

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