NCT02634398撤回不适用
A Post Market ObServational StudY on the Effect of DRG StiMulation in PATients witH Chronic Pain Following Surgical Lumbar DiscectomY (Failed Back Surgery Syndrome): SYMPATHY
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Pain Relief
研究概览
简要总结
The purpose of this Post Market Observational Study is to monitor the effect of the Axium® SCS System in the management of chronic pain following surgical lumbar discectomy in subjects whom are routinely scheduled for treatment with the Axium® SCS System.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Subject is at least 18 years old
- •Subject is able and willing to comply with the follow-up schedule and protocol
- •Chronic pain following surgical lumbar discectomy for at least 6 months
- •Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
- •Minimum baseline pain rating of 60 mm on the VAS in the subjects' primary area of pain
- •Subject is able to provide written informed consent
排除标准
- •Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study
- •Escalating or changing pain condition within the past month as evidenced by investigator examination
- •Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
- •Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
- •Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
- •Subject is unable to operate the device
- •Subjects with indwelling devices that may pose an increased risk of infection
- •Subjects currently has an active infection
- •Subject has participated in another clinical investigation within 30 days
- •Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
- •Subject has been diagnosed with cancer in the past 2 years.
- •Subject has an anatomical spinal abnormality which is anticipated to require further surgery
结局指标
主要结局
Pain Relief
时间窗: Post implantation at; 1 week and 1, 3, 6 and 12 months
Assessed by change in pain intensity on a Visual Analogue Scale (VAS) from pre-treatment baseline
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
终止
不适用
A Post Market Study on Dorsal Root Ganglion (DRG) Stimulation in Failed Back Surgery Syndrome (FBSS)Failed Back Surgery SyndromeNCT02335216Abbott Medical Devices22
已完成
不适用
Obtain Additional Information on Use of CorMatrix ECM (Extracellular Matrix)Coronary DiseaseNCT02073331Aziyo Biologics, Inc.1,420
终止
不适用
A Post Market Cohort With the Spinal Modulation Neurostimulator System in Peripheral NeuropathyPeripheral NeuropathyNCT02349646Abbott Medical Devices33
已完成
不适用
A Post Market Study on the Use of Cormatrix® Cangaroo ECM® (Extracellular Matrix) EnvelopeCardiovascular DiseaseNCT02530970Aziyo Biologics, Inc.1,025
已完成
不适用
MaxAn Post Market Surveillance ValidationDeformityFractureTumorDDDNCT01343693Zimmer Biomet119