Recruiting

NeoCast Embolic System

Sponsor:

Arsenal Medical, Inc.

Code:

NCT07541404

Conditions

Subdural Hematoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

NeoCast Embolic System

Onyx LES, an FDA-Approved Commercial Liquid Embolic

Study Details

Brief 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

Study ID

NCT07541404

Start date

Aug 13, 2026

Status verified date

Sep, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participant whose age is ≥ 18 and ≤ 90 years;
  • Pre-morbid mRS ≤ 2;
  • Confirmed diagnosis of subacute or chronic subdural hematoma that measures ≥10 mm in greatest thickness;
  • Participant presents with one or more of the following corroborating neurological symptoms: headache; cognitive decline; speech difficulty; gait impairment or imbalance; focal neurological deficit; and/or seizure, within the last 30 days;
  • Participant is planned for middle meningeal artery embolization within ±7 days of surgical evacuation of hematoma via burr hole or craniotomy;
  • Participant or Legally Authorized Representative/Person Responsible for consenting on their behalf understands the nature of the procedure, consents to participation in the study and provides a signed informed consent form;
  • Participant (woman of child-bearing potential) with a current negative pregnancy test who has agreed to an appropriate method of contraception throughout the trial;
  • Participant is willing to return to the investigational site for follow-up visits.

Exclusion Criteria:

  • Diagnosed with acute SDH
  • Participant with prior embolization of either MMA
  • Participant with urgent or emergent (within 1 hour of assessment) subdural hematoma evacuation needed
  • Participant with bilateral SDH where both sides require surgery or contralateral SDH >5mm in greatest thickness
  • Participant identified with potentially dangerous anatomic variations leading to increased procedural risk, risk of incomplete embolization, or unsafe access for MMA embolization (i.e., MMA originating from ophthalmic artery)
  • Participant who presents with a meningioma ≥1 cm or < 1 cm with mass effect
  • Subjects with conditions placing them at high-risk for ischemic stroke who cannot be taken off anticoagulants for at least 7 days post-surgery
  • Participant currently undergoing radiation therapy for carcinoma or sarcomas of the head or neck region
  • SDH developed due to underlying condition or structure pathology (e.g., dural AV fistula, AVM, tumor, arachnoid cyst, ventriculoperitoneal shunt, spontaneous intracranial hypotension or previous craniotomy)
  • Presumed microbial superinfection
  • Participant who is breastfeeding
  • Participant with life expectancy of <1 year
  • Participants with acute renal impairment that the investigator assesses could be at risk for contrast induced nephropathy
  • Participant with a life-threatening allergy to radiographic contrast (unless treatment for allergy is tolerated or can be managed medically)
  • Participant is allergic to any of the materials used in the NeoCast device or the Onyx LES commercial embolic device
  • Participant who is currently participating or planning to participate within 6 months in another clinical research study

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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

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

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 ]
  • Safety Outcomes including Device-related or Procedure-related Serious Adverse Events [ Time Frame: 180 days post-treatment ]

Central Contacts and Locations

Central contacts

Carol Pekar, MBA

508-523-5456cpekar@arsenalmedical.com

Locations

University of Washington Medicine - Harborview Medical Center

Recruiting

Seattle, Washington, United States, 98104

More Information

Sponsor

Arsenal Medical, Inc.

Last update posted

Sep 30, 2026

Last verified

Sep, 2026

Keywords

  • Hematoma
  • Chronic subdural hematoma (cSDH)
  • Subacute subdural hematoma
  • Subdural hematoma (SDH)
  • Middle Meningeal Artery (MMA) Embolization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-01. This information was provided to ClinicalTrials.gov by Arsenal Medical, Inc. on 2026-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.