NAVITAS and ENVISION Study: A Study to Characterize the Relationship Between Select Objective Metrics and Clinical Outcomes in Chronic Pain Patients Treated With Boston Scientific Neurostimulation Systems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 544
- 试验地点
- 16
- 主要终点
- Pain Responder Rate
研究概览
简要总结
The objective of the study is to characterize the relationship between select objective metrics and clinical outcomes in chronic pain patients treated with Boston Scientific commercially approved neurostimulation systems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Is willing and able to comply with completing protocol required assessments and evaluations
排除标准
- •- Has any pain-related diagnosis, medical/psychological condition or external factors that, in the investigator's medical judgment, might confound reporting of study outcomes (e.g. history of pelvic pain, anginal pain, chronic migraine, involved in litigation, workmen's compensation)
研究组 & 干预措施
Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study
Patients enrolled in the ENVISION study. Follow-up period is based on date they signed the informed consent and were enrolled into the study.
All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain, except for Precision™ and Precision™ Plus.
干预措施: Neurostimulation System (Device)
Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 SCS Trial Procedure) Navitas Study
Patients enrolled in the NAVITAS study. Follow-up period is based on date of their SCS Trial Procedure.
All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain.
干预措施: Neurostimulation System (Device)
Boston Scientific SCS Systems (Day 0 Implantable Pulse Generator (IPG) Activation) Navitas Study
Patients enrolled in the NAVITAS study. Follow-up period is based on date of their Implantable Pulse Generator (IPG) was activated.
All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain.
干预措施: Neurostimulation System (Device)
结局指标
主要结局
Pain Responder Rate
时间窗: 12 months
Proportion of subjects with 50% or greater reduction in Low Back pain
次要结局
未报告次要终点