NCT06718478已完成不适用
First in Human Study of SakuraBead for Genicular Artery Embolization to Treat Pain Secondary to Knee Osteoarthritis
CrannMed1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年12月5日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Decrease of pain on Visual Analogue Scale (VAS) at 1 month follow-up.
研究概览
简要总结
A prospective, single-centre, single-arm, unmasked, First in Human study that aims to evaluate the safety and efficacy of SakuraBead resorbable microspheres in adult patients suffering from pain secondary to knee osteoarthritis.
详细描述
To evaluate safety and efficacy of SakuraBead for the treatment of pain secondary to knee osteoarthritis. Treatment will be performed on up to 15 patients who will be followed up for a period of 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 is able and willing to provide written informed consent, and
- •Clinical diagnosis of knee OA, and
- •Moderate to severe knee pain (VAS ≥ 5), and
- •Pain refractory to at least 3 months* of conservative therapies (anti-inflammatory drugs, or physical therapy, or muscle strengthening, or intra-articular injections), and
- •Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee, and
- •Age 40 years or older.
- •Subject has confirmed evidence of knee OA, defined as an angiographic 'blush' pattern (radiographic) in one or more of the target genicular artery(ies).
排除标准
- •Severe knee OA (Kellgren-Lawrence grade 4)
- •Current infection of target joint, or
- •Life expectancy less than 24 months, or
- •Known advanced atherosclerosis as defined by history of lower extremity or pelvis arterial bypass graft, lower extremity or pelvis arterial stent placement or prior history of vascular claudication, or
- •Rheumatoid or known serologic diagnosis of autoimmune arthritis, or
- •Prior knee replacement surgery in the target knee, or
- •Complete meniscal or cruciate tear that requires surgery, or
- •History of uncorrectable coagulopathy, or
- •Prior iodinated contrast reaction resulting in anaphylaxis, or
- •Pregnant and/or lactating female, or
- •At the discretion of the Principal Investigator
- •Subject has evidence of arterial occlusion precluding catheterization.
- •Subject has occlusion of the genicular arteries.
研究组 & 干预措施
Genicular Artery Embolization (GAE)
Experimental
Temporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres
干预措施: SakuraBead Resorbable Microspheres (Device)
结局指标
主要结局
Decrease of pain on Visual Analogue Scale (VAS) at 1 month follow-up.
时间窗: 1 month
Genicular Artery Embolization (GAE) without a major device- or procedure-related complication at 1 month follow-up
时间窗: 1 month
次要结局
- Reduction in global Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questionnaire at 1 month, 3 months and 6 months follow-up(1, 3 and 6 months)
- Reduction of previously initiated OsteoArthritis (OA) medical therapy at 3- and 6-months follow-up(3 and 6 months)
- Decrease of pain on Visual Analogue Scale (VAS) at 3 and 6 months(3 and 6 months)
- No major device- or procedure-related complication at 3 and 6 months(3 and 6 months)
研究者
研究点 (1)
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