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
Sponsors and collaborators
Sanford Health
Lead sponsor
phenox Inc.
Collaborator