Comparative Study of Embolic Agents in Patients With Subdural Hemorrhage Undergoing Middle Meningeal Artery (MMA) Embolization

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSanford Health

About this trial

Single site, prospective, comparative effectiveness pilot trial comparing efficacy and safety outcomes of three embolic materials (particles, liquid embolics, and Wallaby Phenox coils) in MMA embolication for cSDH.

Eligibility criteria

Qualifiers

Adult patients (≥ 18 years)

Undergoing Middle Meningeal Artery Embolization (MMAE) for chronic subdural hematoma (cSDH)

Able to provide informed consent or have a legally authorized representative (LAR) do so

Disqualifiers

Ineligible for MMAE procedure, as deemed by the treating physician, for any indication (e.g. pregnancy)

Non-chronic subdural hematoma (cSDH) indications for Middle Meningeal Artery Embolization (MMAE), including acute subdural hematoma with symptom onset < 72 hours or mixed acute/chronic without predominant chronic features

Pregnancy or breastfeeding

Known severe allergy or contraindication to embolic materials (e.g. particles, liquids like Onyx/n-BCA, or coils)

Trial design

Treatments tested in this trial

  • Particles (polyvinyl alcohol or similar microspheres)
  • Liquid Embolics (Onyx, n-BCA, or equivalent)
  • Phenox Coils (Avenir UNO Helical Coil)

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Sanford Health

Lead sponsor

phenox Inc.

Collaborator