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 @ 1:19 PM
Ignite Modification Date:
2025-12-24 @ 1:19 PM
NCT ID:
NCT03307395
Eligibility Criteria:
Inclusion Criteria:
* Age must be greater or equal to 18 years of age.
* Subjects must have a diagnosis of chronic or acute-on-chronic subdural hematoma based on brain imaging, as documented by an independent radiologist.
* One or more symptoms attributable to chronic SDH including headache, cognitive impairment, gait instability, seizure, or mild focal neurologic deficit.
* In the opinion of the site investigator or the subject's referring physician, the subject has failed conservative management.
Exclusion Criteria:
* The subdural hematoma is causing mass effect significant enough to cause marked or progressive neurologic impairment.
* Any requirement for urgent surgical evacuation is necessary.
* Life expectancy is less than 6 months in the opinion of the subject's primary physician.
* Markedly tortuous vasculature precluding safe endovascular access, as assessed on angiogram.
* Acute subdural hematomas.
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT03307395
Study Brief:
Protocol Section:
NCT03307395