NCT03913689已完成不适用
A Prospective, Open-label, Long-term, Multi-center, Registry to Assess the Safety and Efficacy of the Bioness StimRouter Neuromodulation System in Subjects With Chronic Pain of Peripheral Nerve Origin
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bioness Inc
- 入组人数
- 62
- 试验地点
- 9
- 主要终点
- Change in Pain from Screening through 6 Months
研究概览
简要总结
This Registry study will prospectively evaluate the long-term effectiveness, safety, and tolerability of the StimRouter Neuromodulation System, along with evaluating the technical performance of StimRouter, surgical outcomes, health-related quality of life, concomitant medical use, and subject's impression of improvement.
详细描述
This is a prospective, open-label, long-term, multi-center registry. Up to 173 subjects with chronic pain related to peripheral nerve will be enrolled by approximately 15 qualified sites. Subjects who are eligible for a StimRouter will be enrolled in order to evaluate the subject's experience at pre-implant, the implant, and post-implant for up to 24 months. Based on routine care, subjects will be seen at day of implant, within 2 weeks post-implant, 3 months post-implant, 6 months post-implant, 9 months post implant, 12 months post-implant, and 24 month post-implant.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is at least 18 years of age at the time of giving informed consent.
- •Subject who has chronic pain of peripheral nerve origin
- •Subject is eligible for StimRouter as determined by the Clinician.
- •Subject has a score of 5 or higher on the Pain NRS for average pain specific to the area(s) of chronic pain being treated over the past 24 hours
- •Subject is planned to be scheduled for implant of StimRouter.
- •Subject has a life expectancy greater than 6 months as determined by the Clinician.
- •Subject who is able to read, understand, and voluntarily sign the IRB-approved informed consent form prior to the performance of any study-specific procedures.
- •Subject who is able to understand and complete required assessments.
排除标准
- •Subject has other concomitant treatment or medical condition that, in the opinion of the Clinician, prevents the subject from study participation.
- •Subject who, for implantation in the trunk, has an implanted demand-type cardiac pacemaker or defibrillator.
- •Subject has or plans to have a Spinal Cord Stimulator (SCS), Peripheral Nerve field Stimulation System (PNfS), Dorsal Root Ganglion system (DRG), or implantable infusion pump.
- •Subject who has an implanted device in the area for StimRouter implantation without sponsor approval. Maintain a minimum separation distance of 6 inches (15 cm) between the StimRouter system and all other active implanted devices.
- •Subject who requires, or is likely to require, diathermy at the implant site.
- •Subject who requires, or is likely to require, therapeutic ultrasound at the implant site.
- •Subject who has a cancerous lesion present near the target stimulation point.
- •Subject with a bleeding disorder, which, in the opinion of the investigator, is a contraindication to device placement.
- •Subject who has an active systemic infection.
- •Subject who is immunocompromised and/ or determined by the Clinician to be clinically inappropriate for the procedure and implant.
- •Subject who has an active or existing skin disorder or irritation, which, at the Clinician's discretion, precludes the use of skin gel electrodes.
- •Subject who currently require or is likely to require Magnetic Resonance Imaging (MRI) within the MRI exclusion zone: the entire StimRouter lead must be at least 50 cm from the center of the MRI system's bore (the iso-center) and at least 16 cm outside of the MRI coil measured from the edge of the MRI coil.
- •Subject who has a history of adverse reactions to local anesthetic (e.g., lidocaine).
- •Subject who is pregnant, plan on becoming pregnant, or is breastfeeding during the study period.
- •Subject who is participating in any other study that could affect the outcome of the registry, such as a spinal stimulation study.
- •Subject who is in litigation related to their pain, or who has a pending or active worker's compensation claim. (A patient receiving long-term medical care from a settled Worker-s Compensation claim would not be excluded.)
- •Subject who declines to provide written consent or follow-up.
结局指标
主要结局
Change in Pain from Screening through 6 Months
时间窗: Month 6
Change from baseline to 6 months post-permanent implant in aversge pain assessed by using a Numeric Rating Scale
次要结局
- Change in Pain Severity post-implantation(Month 6)
- Change in Pain Interference post-implantation(Month 6)
- Change in Health-related Quality of Life(MOnth 6)
- Change in Patient Global Impression of change(Month 6)
- Patient Treatment Satisfaction(Month 6)
- Pain medication use(Month 6)
研究者
研究点 (9)
Loading locations...
相似试验
招募中
不适用
The Vesalio NeVa Stent Retriever Registry Study for Treatment of Large Vessel Occlusion StrokesAcute Ischemic StrokeNCT03926988Vesalio400
已完成
3 期
A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular EdemaDiabetic Macular EdemaNCT04432831Hoffmann-La Roche1,479
终止
3 期
Extension Study of the Long-term Safety and Tolerability of Octreotide Acetate in Patients With Moderately Severe or Severe Non-proliferative Diabetic Retinopathy or Low Risk Proliferative Diabetic RetinopathyDiabetic RetinopathyNCT00248157Novartis Pharmaceuticals105
终止
3 期
Extension Study of Long-term Safety and Tolerability of Octreotide Acetate in Patients With Moderately Severe or Severe Non-proliferative Diabetic Retinopathy or Low Risk Proliferative Diabetic RetinopathyDiabetic RetinopathyNCT00248131Novartis Pharmaceuticals260
招募中
不适用
Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast CancerHER2-positive Breast CancerEarly-stage Breast CancerNCT06035016Peking Union Medical College Hospital300