Status:
COMPLETED
Dartmouth Middle Meningeal Embolization Trial (DaMMET)
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Conditions:
Chronic Subdural Hematoma
Subdural Hematoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Chronic subdural hematomas (cSDH) are one form of bleeding in the head. They are one of the most common diseases encountered by neurosurgeons across the country. The cSDH can push on the brain and pro...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Have radiographic imaging showing a cSDH \> 7mm in maximal thickness encompassing \> 50% of the convexity (non-focal).
- Capable of giving consent for the procedure or have an acceptable surrogate capable of giving consent on the subject's behalf
Exclusion
- The cSDH is secondary to an underlying vascular malformation, tumor, cyst, spontaneous cerebrospinal fluid hypotension or previous craniotomy
- Life expectancy \< 6 months
- Vascular anatomy that puts the patient at high risk for adverse events (e.g. critical carotid stenosis, abnormal external-internal carotid circulation)
- Incapable of being reasonably expected to be able to attend follow-up appointments at Dartmouth-Hitchcock Medical Center
- Vulnerable patients including homeless patients, incarcerated patients and mentally ill patients without appropriate medical decision-making proxy that the physician believes are incapable of appropriately assessing the risks of the procedure
Key Trial Info
Start Date :
March 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04270955
Start Date
March 11 2020
End Date
January 11 2024
Last Update
February 22 2024
Active Locations (1)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756