NCT02373540终止不适用
Real-world Evaluation of Outcome Data Under a Prospective, Observational, Post-Market Clinical Study, Using the Algovita SCS System to Treat Patients With Chronic Pain of the Trunk and/or Limbs Per the Applicable Indications for Use
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Nuvectra
- 入组人数
- 91
- 试验地点
- 18
- 主要终点
- Percent reduction in targeted pain compared to baseline
研究概览
简要总结
The purpose of this study is to obtain real-world clinical outcome data for the Algovita Spinal Cord Stimulation system when used, on-label, according to the applicable directions for use.
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
- •Patient is eligible for SCS therapy according to the Algovita SCS system Indications for Use statement
- •Patient had successful Algovita SCS system stimulation trial with an Algovita SCS system and will be implanted with a permanent Algovita SCS system; prior approval must be obtained from the Sponsor if another SCS system was used for the stimulation trial
- •Patient is willing and able to sign an IRB/EC approved informed consent, and in the United States, a Privacy Protection Authorization, as required
排除标准
- •Patient is contraindicated for an Algovita SCS system
- •Patient has a cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments
- •Patient has a life expectancy of less than 2 years
- •Patient is participating in another clinical study that would confound data analysis
- •Patient has a coexisting pain condition that might confound pain ratings
结局指标
主要结局
Percent reduction in targeted pain compared to baseline
时间窗: 6 Month Follow-up Visit
Percentage of participants who experience at least a 50 percent reduction in targeted pain from baseline, as assessed by Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.
次要结局
- Rate of device-related and/or procedure-related Adverse Events (AEs)(From Implant through 24 Month Follow-up Visit)
- Change in quality of life compared to baseline(1, 3, 6, 12, 18, and 24 Month Follow-up Visits)
- Percent reduction in targeted pain compared to baseline(1, 3, 12, 18, and 24 Month Follow-up Visits)
- Percent change in targeted pain intensity compared to baseline(1, 3, 6, 12, 18, and 24 Month Follow-up Visits)
- Rate of surgical intervention of the SCS system(From Implant through 24 Month Follow-up Visit)
- Change in disability compared to baseline(1, 3, 6, 12, 18, and 24 Month Follow-up Visits)
- Willingness to undergo procedure again(1, 3, 6, 12, 18, and 24 Month Follow-up Visits)
研究者
研究点 (18)
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