Recruiting

MMA Embolization

Sponsor:

Cerenovus, Part of DePuy Synthes Products, Inc.

Code:

NCT06735833

Conditions

Migraine Disorders

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Middle Meningeal Artery embolization

Study Details

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.

Conditions

Migraine Disorders

Study ID

NCT06735833

Start date

Apr 23, 2025

Status verified date

Aug, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Dec 25, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Participant 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 primary headache types, or secondary headache types except medication overuse headache
2. Patients with diagnosis of hemiplegic migraine or migrainous infarct
3. Patients with current regular use of Opioids, Cannabis, Medical Marijuana, etc
4. Women who are pregnant, lactating, or who are of childbearing age
5. Current involvement in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Participants in observational, natural history, and/or epidemiological studies not involving intervention are eligible. Sponsor approval is required

Study Design

Enrollment

70 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Interventions

Middle Meningeal Artery embolization

Bilateral middle meningeal artery embolization using TRUFILL n-BCA liquid embolic system

Primary outcome measure

  • Change from baseline, in number of migraine days [ Time Frame: over 28 days post study intervention ]

Central Contacts and Locations

Central contacts

Locations

John Muir Physician Network Clin. Research Center

Recruiting

Walnut Creek, California, United States, 94598

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06032

Mount Sinai

Recruiting

New York, New York, United States, 10029

Stony Brook University Medical Center

Recruiting

Stony Brook, New York, United States, 11794

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Semmes Murphey Foundation

Recruiting

Memphis, Tennessee, United States, 38120

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

More Information

Sponsor

Cerenovus, Part of DePuy Synthes Products, Inc.

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Cerenovus, Part of DePuy Synthes Products, Inc. on 2026-08-28.