Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-24 @ 9:49 PM
NCT ID:
NCT04402632
Eligibility Criteria:
Inclusion Criteria:
* Pre-morbid Modified Rankin Score ≤3
* Confirmed diagnosis of subacute or chronic subdural hematoma
* Completed informed consent
* Meets criteria for Surgery or Observation Cohort
Exclusion Criteria:
* Life expectancy \<1 year
* Unable to complete follow-up
* Pregnant, lactating, or has a positive pregnancy test at time of admission
* Diagnosed with acute SDH
* Potentially dangerous anatomic variations leading to increased procedural risk or unsafe access for MMA embolization
* Pre-randomized Markwalder Grading Scale score ≥ 3
* Unmanaged, uncontrolled bleeding disorders/blood diathesis
* Presumed septic embolus, or suspicion of microbial superinfection
* Known active COVID-19 infection
* CT or MRI evidence of intra-cranial tumor or mass lesion Contraindication to angiography
* Participation in another clinical trial
* Contraindicated for the use of Onyx™ LES
* Cannot be taken off corticosteroids (intended to treat subacute or chronic SDH) for at least 90 days post-randomization
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04402632
Study Brief:
Protocol Section:
NCT04402632