Спонсор: Cerenovus, Part of DePuy Synthes Products, Inc.
Налично на:
БГ
Обобщение
This is a prospective, multi-center, feasibility study to investigate safety and effectiveness of TRUFILL n-BCA liquid embolic system in bilateral middle meningeal artery (MMA) embolization for the treatment of refractory chronic migraine.
Кой може да участва
Participant Inclusion Criteria, Candidates for this study must meet ALL the following inclusion criteria:
1. Patient is between 18 and 65 years of age (inclusive) at the time of consent.
2. Age of onset of Chronic Migraine ≤ 64 years.
3. Age of onset of migraine diagnosis \< 50 years.
4. Patient has a current diagnosis of refractory migraine.
5. Patient has a current diagnosis of Chronic migraine.
Participant Exclusion Criteria, Candidates will be excluded from participation if ANY of the following apply:
1\. Patients with a history for the last 2 years of other types of headache. 2. Patients with diagnosis of hemiplegic migraine or migrainous infarct. 5. Patients with current regular use of Opioids, Cannabis, Medical Marijuana, etc.
6\. Women who are pregnant, lactating, or who are of childbearing age. 7. Current involvement in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible. Sponsor approval is required.
Интервенции
Middle Meningeal Artery embolization
DEVICE
Места на провеждане
9
САЩ (9)
University of Buffalo Medical Center
Buffalo , New York
NOT_YET_RECRUITING
Hartford Hospital
Hartford , Connecticut
NOT_YET_RECRUITING
Semmes Murphey Foundation
Memphis , Tennessee
West Virginia University
Morgantown , West Virginia
Mount Sinai
New York , New York
Thomas Jefferson University Hospital
Philadelphia , Pennsylvania
Barrow Neurological Institute at St. Joseph's Hospital