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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Sanford USD Medical Center
Sioux Falls, South Dakota, United States
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
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