CompletedNot Applicable

Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA

United States376 participantsStarted 2021-05-27

Plain-language summary

This is a prospective, multi-center, open-label, randomized controlled study in which subjects can receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization for the treatment of chronic subdural hematomas (cSDH).

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Pre-randomization mRS \</= 3 * Confirmed diagnosis of chronic subdural hematoma * Completed informed consent Exclusion Criteria: * Acute subdural hematoma * Prior treatment of target subdural hematoma * Markwalder assessment \>/= 3 * Glasgow Coma Scale \< 9 * Presumed microbial superinfection * CT or MRI evidence of intracranial tumor or mass lesion * Life expectancy \< 1 year * Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during the study * Current involvement in another clinical trial that may confound study endpoints

What they're measuring

Residual or Re-accumulation of the Chronic Subdural Hematoma (cSDH) (Greater Than [>] 10 Millimeter [mm]) as Assessed by an Independent Core Laboratory OR Any Re-operation or Surgical Procedure on the cSDH at 6 Months

Timeframe: At 6 months

Percentage of Participants With All Adverse Events (AEs)

Timeframe: From randomization up to 6 months

Trial details

NCT IDNCT04816591

SponsorCerenovus, Part of DePuy Synthes Products, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-15

Results submitted2026-01-14

View on ClinicalTrials.gov More Chronic Subdural Hematoma trials