Precision Spectra™ Neurostimulator System for the Treatment of Chronic Intractable Pain of the Trunk and/or Limbs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- Proportion of Subjects Satisfied With Treatment in a Sub-group Utilizing More Than 2 IPG Ports at 365 Days Post-IPG Implantation
研究概览
简要总结
The primary objective of this study is to investigate patient satisfaction with treatment using a new implantable neurostimulation system for chronic pain of the trunk and/or limbs.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic intractable pain of the trunk and/or limbs
- •Documented history of trunk and/or limb pain of at least 180 days
- •Overall pain intensity of at least 5 on a 0-10 numerical rating scale (OPI-NRS-11) over the past 180 days based on subject recall
- •Pass study site's routine psychological/psychiatric evaluation within 180 days before signing the informed consent
- •Subject is willing and able to comply with all protocol-required follow-up evaluations
- •18 years of age or older when written informed consent is obtained
- •Subject signs informed consent
排除标准
- •Unable to operate the Precision Spectra™ System either by self or with a caregiver
- •Primary source of pain is cancer-related, pelvic, visceral, anginal or migraine
- •Overall pain intensity of always 10 on a 0-10 numerical rating scale (OPI-NRS-11) over the past 180 days based on subject recall
- •Is a high surgical risk
- •Currently on any anticoagulant medications that cannot be discontinued during perioperative period
- •Subject requires Magnetic Resonance Imaging (MRI) while implanted with lead(s) and/or the Precision Spectra IPG
- •Subject is participating (or intends to participate) in another investigational drug or device clinical trial that may influence the data that will be collected for this study
- •Subjects already implanted with an active implantable device(s) to treat their pain (IPGs, implantable drug pumps, etc) or pacemaker or Implantable Cardiac Defibrillator
- •Patient is a woman who is pregnant (a urine pregnancy test must be performed within 7 days prior to the stimulation trial procedure in women of child-bearing potential) or nursing or intends to become pregnant during the course of the trial.
- •Failed to achieve satisfactory relief during the stimulation trial phase
结局指标
主要结局
Proportion of Subjects Satisfied With Treatment in a Sub-group Utilizing More Than 2 IPG Ports at 365 Days Post-IPG Implantation
时间窗: 365 days post permanent implantation
Proportion of subjects in a sub-group utilizing more than 2 IPG ports at 365 Days post-IPG implantation satisfied with treatment, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire.
Proportion of Subjects Satisfied With Treatment at 90 Days Post-IPG Implantation
时间窗: 90-days post permanent implantation
Proportion of subjects satisfied with treatment at 90 days post-IPG implantation, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire.
次要结局
未报告次要终点