NCT06872567招募中不适用
Resorbable Embolization MicroSpheres for OsteoaRthritis Benefit
North American Science Associates Ltd.1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2025年10月1日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
研究概览
简要总结
Multi-center, prospective, randomized trial of GAE using Nexsphere-F against steroid injection
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has localized knee pain
- •Must be an appropriate candidate for arterial vascular access procedure
排除标准
- •Known sensitivity or allergy to implant materials
- •Unable or unwilling to comply with study requirements
研究组 & 干预措施
Control
Active Comparator
干预措施: Corticosteroid Injection (Drug)
Device: GAE
Experimental
干预措施: genicular artery embolization (Device)
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: 6 and 12-month post treatment
Changes in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Scale ranges from 0 to 96 with higher scores equating to greater pain, stiffness and difficulty with activities of daily living.
Serious Adverse Events (SAE)
时间窗: Treatment, 1,3,6,9 and 12-month post treatment
次要结局
- WOMAC total score(9 month post treatment)
研究者
研究点 (1)
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