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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Middle Meningeal Artery embolization | Device | Bilateral middle meningeal artery embolization using TRUFILL n-BCA liquid embolic system |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline, in number of migraine days | over 28 days post study intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in migraine days frequency | 3 months and 6 months post study intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse events | At 4 weeks, 3 months, 6 months and 1 Year post study intervention |
Participant Inclusion Criteria, Candidates for this study must meet ALL the following inclusion criteria:
Participant Exclusion Criteria, Candidates will be excluded from participation if ANY of the following apply:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | RA-MIGRAINECNV202302@ITS.JNJ.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute at St. Joseph's Hospital | Withdrawn | Phoenix | Arizona | 85013 | United States | |
The data sharing policy of Johnson & Johnson MedTech is available at www.jnj.com/innovativemedicine/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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This is a prospective, multi-center, feasibility study in which up to 70 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 10 US centers.
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| John Muir Physician Network Clin. Research Center |
| Not yet recruiting |
| Walnut Creek |
| California |
| 94598 |
| United States |
| Hartford Hospital | Recruiting | Hartford | Connecticut | 06032 | United States |
| University of Buffalo Medical Center | Not yet recruiting | Buffalo | New York | 14203 | United States |
| Mount Sinai | Recruiting | New York | New York | 10029 | United States |
| Stony Brook University Medical Center | Recruiting | Stony Brook | New York | 11794 | United States |
| Thomas Jefferson University Hospital | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| Semmes Murphey Foundation | Recruiting | Memphis | Tennessee | 38120 | United States |
| West Virginia University | Recruiting | Morgantown | West Virginia | 26506 | United States |
| D009422 | Nervous System Diseases |