NCT07576998尚未招募不适用
PHIL™ (Precipitating Hydrophobic Injectable Liquid) Middle Meningeal Artery Embolization (MMAE) for First-Line Treatment of Chronic Subdural Hematoma (cSDH) IDE Trial (PHILFIRST)
Microvention-Terumo, Inc.0 个研究点目标入组 475 人开始时间: 2026年12月31日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 475
研究概览
简要总结
This is a prospective, randomized, controlled, open-label, blinded endpoint (PROBE) clinical investigation in which patients with non-emergent chronic subdural hematoma (cSDH) requiring treatment will be randomized (1:1) to either initial surgical evacuation (Control Arm) or initial MMAE with PHIL™ (investigational arm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Sponsor is blinded
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 22 years or older
- •Diagnosis of chronic subdural hematoma
- •Subject, or their legally authorized representative provides a signed and dated Informed Consent Form
- •Pre-morbid mRS 0-1
- •cSDH measures ≥ 10 mm in greatest thickness
- •cSDH exerts mass effect upon the subjacent brain
- •Imaging characteristics indicative of chronicity
- •Negative urine pregnancy test for female subjects of child-bearing potential
- •Subject is able and willing to comply with all study protocol requirements, including return to the investigational site for all follow-up visits
- •Subject presents with one or more of the following neurological symptoms: headache/head pressure, cognitive decline, speech difficulty or aphasia, gait impairment or imbalance, focal neurological deficit (weakness, paresthesia or sensory deficit involving of one or more extremities or facial droop), and/or seizure
排除标准
- •Prior ipsilateral craniotomy or burr hole evacuation of cSDH
- •Prior embolization of either MMA
- •Requires (in the opinion of the treating surgeon) full or mini-craniotomy at time of randomization
- •Emergent subdural hematoma evacuation needed
- •cSDH with a focal location
- •cSDH developed due to underlying condition
- •Life expectancy of <1 year
- •Presents with an intracranial mass other than subdural hematoma
- •Presents with a meningioma with mass effect and/or ≥1 cm or currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region
- •Serum creatinine level > 3.0 mg/dL at time of enrollment and not on dialysis
- •Life-threatening allergy to radiographic contrast (unless treatment for allergy is tolerated or can be managed medically)
- •Currently enrolled in another investigational study protocol that could potentially confound the interpretation of the study endpoints/outcomes
- •Known dangerous anatomic variations leading to increased procedural risk or unsafe access for MMAE
- •Contraindicated for the use of PHIL™ liquid embolic system
研究者
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