MMA Embolization for Refractory Chronic Migraine

Description

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.

Conditions

Migraine

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Study Overview

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Study Details

Study 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.

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

MMA Embolization for Refractory Chronic Migraine

Condition
Migraine
Intervention / Treatment

-

Contacts and Locations

New York

Mount Sinai, New York, New York, United States, 10029

Stony Brook

Stony Brook University Medical Center, Stony Brook, New York, United States, 11794

Philadelphia

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States, 19107

Memphis

Semmes Murphey Foundation, Memphis, Tennessee, United States, 38120

Morgantown

West Virginia University, Morgantown, West Virginia, United States, 26506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cerenovus, Part of DePuy Synthes Products, Inc.,

Study Record Dates

2028-12-29