High-Frequency Nerve Block for Post-Amputation Pain: A Pivotal Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 607
- 试验地点
- 44
- 主要终点
- Primary Effectiveness Endpoint: Reduction of Pain Level by 50% From Baseline
研究概览
简要总结
The purpose of the clinical trial is to learn whether electrical nerve block via the Altius System is a safe and effective treatment for patients with post-amputation pain.
详细描述
The Altius System is an implanted device designed to electrically block nerve signals and alleviate pain. Use of this device may be associated with providing an effective, mechanism-based yet non-destructive, treatment for managing intractable limb pain in amputees. In a given patient, the Altius System will be deemed effective if treatment results in 50% reduction of pain score for more than 50% of all pain episodes.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 21 years old
- •Unilateral amputated leg ≥ 12 months
- •Chronic post amputation pain ≥ 6 months
- •Pain episodes typically lasting ≥ 60 minutes
- •Stable drug regimen ≥ 4 weeks
- •No changes to medications or prosthesis for 3-month primary study period
排除标准
- •Implanted with an active implantable medical device (i.e. pacemaker)
- •Confounding source of pain that interferes with reporting of limb pain
- •Uncontrolled diabetes
- •Spasticity preventing full range of motion of involved side
- •Extremely short stump; sits on end
- •Untreated psychological condition (i.e. borderline personality)
- •Condition requiring MRI studies or diathermy after device implant
- •Life expectancy of less than 24 months
- •Progressive neurological disease (i.e. multiple sclerosis)
- •Subjects with active local or systemic infection or immunocompromised
结局指标
主要结局
Primary Effectiveness Endpoint: Reduction of Pain Level by 50% From Baseline
时间窗: Randomized Testing Window (Month-1 to Month-3 post implant, 2 Month duration)
Demonstration of 50% reduction in a Numerical Rating Scale (NRS; 0-10 Scale; with 10 being the highest pain imaginable) pain score from pre-treatment to post-treatment for more than 50% of all pain episodes. Study success will be determined by a superiority test on the difference between responder rates in the Test group (those receiving the treatment) and Control group (those who do not receive treatment).
Primary Safety Endpoint: Incidence of Reported and Adjudicated Serious Adverse Events
时间窗: From screening injection visit through 3 months post implant
Incidence of all serious adverse events including serious adverse device events and unanticipated adverse device events.
次要结局
- Secondary Effectiveness: Pain Relief After 2 Hours(12 months post implant)
- Secondary Effectiveness: Pain Medication Use(12 months post implant)
- Secondary Effectiveness: Pain Interference to Activities of Daily Living (ADL(12 months post implant)
- Secondary Effectiveness: Health-related Quality of Life (HR-QOL)(12 months post implant)
- Secondary Effectiveness: Patient Global Impression of Change (PGIC)(12 months post implant)
- Secondary Safety(12 months post implant)