An interventional study of Particles (polyvinyl alcohol or similar microspheres) and Liquid Embolics (Onyx, n-BCA, or equivalent) in Chronic Subdural Hematoma, Stroke and Middle Meningeal Artery Embolization, sponsored by Sanford Health. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Sanford Health · Not applicable, Interventional, and Treatment
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.
Participants will be sequentially enrolled into one of three treatment arms based on the embolic material used during their MMA embolization:
Cohort/Arm 1: Particles (polyvinyl alcohol or similar microspheres) Cohort/Arm 2: Liquid embolics (Onyx, n-BCA, or equivalent) Cohort/Arm 3: Phenox coils (Avenir UNO Helical Coil) Participants will remain on study through their standard 30- and 90-day follow-up visits.
With a target of 30 patients (10 per arm), the study will provide preliminary data on radiographic efficacy (primary: hematoma resolution/thickness reduction), safety (complications, recurrence, adverse events, reinterventions), and exploratory outcomes (symptom/functional improvement, procedural metrics, influence of comorbidities/antithrombotics).
112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.
This study's planned enrollment of 30 is below the median of 185 across 86 interventional studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →Sanford Health is the lead sponsor of 39 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be sequentially assigned one of three MMAE treatment strategies (particles, liquid embolics, or coils) in the order they become eligible and agree to participate. Radiographic and clinical outcomes will be compared.
Device: Particles (polyvinyl alcohol or similar microspheres) · Device: Liquid Embolics (Onyx, n-BCA, or equivalent) · Device: Phenox Coils (Avenir UNO Helical Coil)
Participants will be sequentially enrolled into one of three clinically accepted MMAE treatment strategies (interventions) to compare radiographic and clinical outcomes.
Participants will be sequentially enrolled into one of three clinically accepted MMAE treatment strategies (interventions) to compare radiographic and clinical outcomes.
Participants will be sequentially enrolled into one of three clinically accepted MMAE treatment strategies (interventions) to compare radiographic and clinical outcomes.
Change in hematoma size
The primary objective aims to compare the radiographic efficacy of three embolic materials (particles, liquid embolics, Phenox coils) in MMA embolization for cSDH to evaluate change in hematoma size.
Time frame: Baseline, 90 days
Complications
The secondary objectives aim to evaluate the safety profile of the embolic materials, to support overall comparative effectiveness.
Time frame: Baseline, 90 days
Recurrence Rates
The secondary objectives aim to evaluate the the safety profile of the embolic materials, to support overall comparative effectiveness.
Time frame: Baseline, 90 days
Adverse Events
The secondary objectives aim to evaluate the the safety profile of the embolic materials, to support overall comparative effectiveness.
Time frame: Baseline, 90 days
Re-Intervention Rates
The secondary objectives aim to evaluate the the safety profile of the embolic materials, to support overall comparative effectiveness.
Time frame: Baseline, 90 days
Plan to share: No
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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