Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Chronic Subdural Hematoma
• Age: Between 30 years - 99 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Chronic Subdural Hematoma (cSDH) measures = 10 mm in greatest thickness.
  2. cSDH exerts mass effect upon the subjacent brain, Indicated by local cortical flattening and/or midline shift.
  3. Participant presents with one or more of the following neurological symptoms:
     • headache;
     • cognitive decline;
     • speech difficulty or Aphasia;
     • gait impairment or imbalance;
     • focal neurological deficit (weakness, paresthesia or sensory deficit involving of one or more extremities or facial droop); and/or
     • seizure.
  4. Participant, or his/her legally authorized representative, understands the nature of the procedure, consents to participation in the study and provides a signed Informed Consent.
  5. Female Participants of child-bearing potential must be able to provide a current negative urine pregnancy test and agree to an appropriate method of contraception throughout the trial.
  6. Participant is able and willing to return to the investigational site for all follow-up visits (e.g., 30- day, 90-day, 180-day and 1-year), as required per protocol.

  
  

You may not be eligible for this study if the following are true:

• 1. Participant with prior ipsilateral craniotomy or burr hole evacuation of cSDH.
  2. Participant with prior Embolization of either Middle Meningeal Artery (MMA).
  3. Participant requires (in the opinion of the treating surgeon) a full or mini craniotomy.
  4. Participant with urgent or emergent (within 1 hour of assessment) subdural hematoma evacuation needed.
  5. Participant with a cSDH with a focal location (confined to the frontal or temporal base or the inter- hemispheric space without cerebral convexity involvement).
  6. Participant with cSDH < 10 mm in thickness
  7. cSDH without associated mass effect (no cortical flattening or midline shift).
  8. cSDH developed due to underlying condition such as a vascular lesion, brain tumor, arachnoid cyst, spontaneous intracranial hypotension or secondary to a previous craniotomy.
  9. Life expectancy of < 1 year
  10. Participant who presents with an intracranial mass other than subdural hematoma.
  11. Participant who presents with a meningioma with mass effect and/or =1 cm or currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region.
  12. Participant with significant liver function impairment at time of enrollment.
  13. Participant with a life-threatening allergy to radiographic contrast (unless treatment for allergy is tolerated or can be managed medically).
  14. Participant who is currently participating in another clinical research study.
  15. Participant who is unable to complete the required follow-up.
  16. Female participant who is pregnant and/or breastfeeding.
  17. Patient who is currently enrolled in another investigational study protocol that could potentially confound the current study endpoints.