Feasibility Study to Evaluate the Initial Safety and Effectiveness of TRUFILL n-BCA Liquid Embolic System in Middle Meningeal Artery Embolization for the Preventive Treatment of Refractory Chronic Migraine

Cerenovus, Part of DePuy Synthes Products, Inc.12 sites in 1 country70 target enrollmentApril 23, 2025

ConditionsMigraine

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Migraine
Sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.
Enrollment: 70
Locations: 12
Primary Endpoint: Change from baseline, in number of migraine days
Status: Recruiting
Last Updated: 15 days ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 23, 2025

End Date

May 15, 2029

Last Updated

15 days ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cerenovus, Part of DePuy Synthes Products, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participant Inclusion Criteria, Candidates for this study must meet ALL the following inclusion criteria:
•Patient is between 18 and 65 years of age (inclusive) at the time of consent.
•Age of onset of Chronic Migraine ≤ 64 years.
•Age of onset of migraine diagnosis \< 50 years.
•Patient has a current diagnosis of refractory migraine.
•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.
•Patients with diagnosis of hemiplegic migraine or migrainous infarct.
•Patients with current regular use of Opioids, Cannabis, Medical Marijuana, etc.
•6\. Women who are pregnant, lactating, or who are of childbearing age.
•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.