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MMA Embolization for Refractory Chronic Migraine

NCT ID: NCT06735833

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-23

Study Completion Date

2028-12-29

Brief Summary

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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.

Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Interventions

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Middle Meningeal Artery embolization

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cerenovus, Part of DePuy Synthes Products, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mount Sinai

New York, New York, United States

Site Status RECRUITING

Stony Brook University Medical Center

Stony Brook, New York, United States

Site Status RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status NOT_YET_RECRUITING

Semmes Murphey Foundation

Memphis, Tennessee, United States

Site Status RECRUITING

West Virginia University

Morgantown, West Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Study Contact

Role: CONTACT

Phone: 2165439491

Email: [email protected]

Other Identifiers

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CNV202302

Identifier Type: OTHER

Identifier Source: secondary_id

CNV202302

Identifier Type: -

Identifier Source: org_study_id