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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

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 University Medical Center
Stony Brook, New York 11794

Semmes Murphey Foundation
Memphis, Tennessee 38120

More Details

NCT ID
NCT06735833
Status
Recruiting
Sponsor
Cerenovus, Part of DePuy Synthes Products, Inc.

Study Contact

Study Contact
2165439491
RA-MIGRAINECNV202302@ITS.JNJ.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center