MMA Embolization for Refractory Chronic Migraine
Purpose
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.
Condition
- Migraine
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- This is a prospective, multi-center, feasibility study in which up to 50 subjects will be consented to achieve a total of 30 subjects treated with TRUFILL n-BCA bilateral middle meningeal artery (MMA) embolization for the treatment of refractory chronic migraine in up to 5 US centers.
- Primary Purpose
- Device Feasibility
- Masking
- None (Open Label)
Recruiting Locations
Stony Brook, New York 11794
Memphis, Tennessee 38120
More Details
- NCT ID
- NCT06735833
- Status
- Recruiting
- Sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.