NCT06735833招募中不适用
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.13 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年4月23日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 13
- 主要终点
- Change from baseline, in number of migraine days
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •, Candidates will be excluded from participation if ANY of the following apply:
- •Patients with a history for the last 2 years of other primary headache types, or secondary headache types except medication overuse headache
- •Patients with diagnosis of hemiplegic migraine or migrainous infarct
- •Patients with current regular use of Opioids, Cannabis, Medical Marijuana, etc
- •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. Participants in observational, natural history, and/or epidemiological studies not involving intervention are eligible. Sponsor approval is required
结局指标
主要结局
Change from baseline, in number of migraine days
时间窗: over 28 days
次要结局
- Change from baseline in migraine days frequency(3 months and 6 months)
研究者
研究点 (13)
Loading locations...
相似试验
招募中
不适用
Treatment of Pulmonary Arterial Hypertension Using the Aria CV Pulmonary Hypertension SystemRight Heart DysfunctionPulmonary Arterial HypertensionPulmonary HypertensionNCT04555161Aria CV, Inc30
已完成
不适用
Feasibility Trial of ValenTx Endo Bypass System of the ValenTx Endo Bypass System in Obese SubjectsObesityNCT01207830ValenTx, Inc.10
终止
不适用
Safety and Efficacy Study of The Combined Ablation Procedure To Treat Longstanding Persistent Atrial FibrillationAtrial FibrillationNCT01103661nContact Surgical Inc.7
终止
不适用
Safety and Efficacy Study of the Combined Ablation Procedure to Treat Paroxysmal Atrial FibrillationParoxysmal Atrial FibrillationNCT01103674nContact Surgical Inc.1
Unknown
不适用
Feasibility Trial Evaluating Efficacy and Safety of Solitaire™ Thrombus Retrieval Device in the Management of Refractory Thrombus in Patients With Acute Coronary SyndromeRefractory Thrombus in Patients With Acute Coronary SyndromeNCT04692402Paul Ong51