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Recruiting Not applicable NCT06735833

MMA Embolization for Refractory Chronic Migraine

No applicable phase (e.g. observational)
Conditions: Migraine

Sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
Middle Meningeal Artery embolization
DEVICE
Locations 9
United States (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
Phoenix , Arizona
NOT_YET_RECRUITING
Stony Brook University Medical Center
Stony Brook , New York
John Muir Physician Network Clin. Research Center
Walnut Creek , California
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
23.04.2025
Completion date
15.05.2029
Registry ID
NCT06735833
Source
clinicaltrials.gov
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