NCT04693650已完成不适用
A Prospective, Multi-site, Randomized, Sham-Controlled, Double-Blind Trial With One-Way Crossover Designed to Assess the Effectiveness and Safety of the Gimer NeuroBlock SCS Trialing System for the Treatment of Chronic Back Pain and/or Lower Limb Pain
GiMer Medical4 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2021年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Safety: AEs and SAEs
研究概览
简要总结
This study is a prospective, multi-site, randomized, shamcontrolled, double-blind trial with one-way crossover designed to assess the effectiveness and safety of the Gimer NeuroBlock SCS Trialing System for the treatment of chronic back pain and/or lower limb pain. The NeuroBlock SCS Trialing System is an ultra-high frequency SCS device for the treatment of patients with chronic back pain and/or lower limb pain who are refractory to conservative pain management. After screening procedures, eligible subjects will enter the study which is comprised of a 1-week randomized testing period, a 1-week follow-up period and 2-week observation period.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has been diagnosed with chronic, intractable pain of the trunk and/or limb(s) and is refractory to conservative therapy for a minimum of six months prior to the screening/baseline visit.
- •Subject has an average pain score of back or leg ≥ 5 or maximum pain score of back or leg ≥ 7 on the Visual Analogue Scale (VAS).
- •Subject is willing and able to comply with the procedure and requirements of this trial.
- •The subject is able to understand and provide informed consent, and has signed their written informed consent in accordance with IRB requirements.
排除标准
- •Subject has the following conditions by investigator's discretion at screening visit or during the last 3 months:
- •has the mental or psychological condition that affects pain perception or
- •has difficulty performing objective pain assessment or lack of suitability for participation in the study.
- •Subject has exhibited unstable pain condition within the past 28 days as interviewed by Investigator.
- •Subject has a currently diagnosed coagulation disorder, bleeding diathesis, progressive peripheral vascular disease with PLT < 100,000/μl or INR > 1.4 at screening visit.
- •Subject has unstable pain medication(s) for at least 28 days at investigator's discretion.
- •Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump or subject requires magnetic resonance imaging (MRIs) or diathermy.
- •Subject has a current diagnosis of cancer with active symptoms.
- •Subject has a known terminal illness with life expectancy less than one year.
- •Subject has a systematic or local infection, which may increase study risk.
- •Subject currently has an indwelling device that may pose an increased risk of infection.
- •Subject is pregnant or breast feeding.
- •Subject has a medical history of drug or alcohol addiction within the past 2 years.
- •Subject has participation in any investigational study in the last 30 days or current enrollment in any trial.
- •Subject is currently involved in an injury claim law suit or medically related litigation, including workers compensation.
- •Subject is a prisoner.
结局指标
主要结局
Safety: AEs and SAEs
时间窗: 4 weeks
Incidence of adverse events (AEs) and serious AEs (SAEs)
Effectiveness: Responder Rate
时间窗: 2 weeks
The responder rate of the test group and control group at the 2-week visit
次要结局
未报告次要终点
研究者
研究点 (4)
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