SakuraBead Used as Resorbable Embolic for Plantar Fascia Embolization
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Primary Effectiveness Endpoint
研究概览
简要总结
This is a prospective, single center, double arm, randomized, unmasked, First in Human study that aims to evaluate the safety and effectiveness of SakuraBead™ resorbable embolization microspheres in adult patients suffering from pain secondary to plantar fasciitis.
详细描述
To compare safety and efficacy of SakuraBead with shockwave therapy for the treatment of pain secondary to plantar fasciitis. Treatment will be performed on a total of approximately 45 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（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
- •Age 18 to 75 years (inclusive), and
- •Clinical diagnosis of PF with proximal plantar fascia thickness greater than 4mm and areas of hypoechogenicity.
排除标准
- •Acute internal derangement of the foot including acute meniscal, ligament or bone injury, or
- •Sensory or motor neuropathy of the feet, or
- •Heel pain caused by stress fractures, nerve entrapment, or inflammatory conditions such as arthritis, gout, or bursitis, or
- •Prior surgical repair or plantar fascia rupture in the involved foot, or
- •Local infection in either foot, or
- •Contraindication to MRI, or
- •Active pregnancy as demonstrated by urine or serum β-hCG or lactating female
- •Unable to provide informed consent or comply with the conditions of the study, or
- •At the discretion of the Principal Investigator
研究组 & 干预措施
Shockwave
Extracorporeal Shockwave Therapy (ESWT); a non-invasive therapeutic approach used to treat a variety of musculoskeletal conditions, including plantar fasciitis.
干预措施: Extracorporeal shockwave therapy (Device)
Arterial Embolisation
Temporary embolization using resorbable microspheres
干预措施: Arterial Embolization (Device)
结局指标
主要结局
Primary Effectiveness Endpoint
时间窗: 3 Months
Compare the proportion of responders between the Investigational procedure and Control.
Primary Safety Endpoint
时间窗: 3 months
Freedom from device or procedure-related serious adverse events (SAE) following the index procedure (proportions will be compared between Investigational procedure and Control).
次要结局
未报告次要终点