A Post-Market Study Evaluating the Prodigy MRI and Proclaim Elite MR Conditional SCS Systems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 10
- 主要终点
- The Rate of the MRI Scan-related Adverse Events
研究概览
简要总结
A post market study evaluating the safety of the Prodigy MRI and Proclaim Elite MR conditional Spinal Cord Stimulator (SCS) systems.
详细描述
The study will be performed as an international, multicenter, prospective and single-arm design. The study will be conducted as a Post Market Clinical Follow Up (PMCF) study and the results will be submitted to the Notified Body: BSI Group (BSI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patient has been implanted with a Prodigy MRI or Proclaim Elite MR conditional SCS system
- •Patient will receive an MRI scan in compliance with the Instructions For Use (IFU) for the implanted MR conditional SCS system
- •Patient is ≥ 18 years of age
- •Patient must be willing and able to comply with study requirements
- •Patient must indicate his/her understanding of the study and willingness to participate by signing an appropriate Informed Consent Form
排除标准
- •Patient has another implanted device (active or passive) that prohibits safe scanning
- •Patient has previously experienced an MRI scan-related adverse event
- •Patient is currently enrolled in another Abbott study that collects MRI safety data
- •Patient is incapacitated, is unable to read or write, or is pregnant or breastfeeding
研究组 & 干预措施
Prodigy MRI or Proclaim Elite MR
The Prodigy MRI system is only MR conditional for scans of the head and extremities (upper except shoulder, lower except hip).
The Proclaim Elite system is MR conditional for scans of the head, extremities or any other body part.
干预措施: MRI scan (Procedure)
结局指标
主要结局
The Rate of the MRI Scan-related Adverse Events
时间窗: 1 month post MRI scan
The rate of the MRI scan-related adverse events will be assessed at 1-month follow-up.
次要结局
- Rate of Successful 'Turn on/Off' Functionality for the Stimulation(At 1 month follow-up)
- Rate of Successful Adjustments to the Program(At 1-month follow-up)
- Rate of Successful 'Turn on' Functionality for the Stimulation(Immediately after MRI Scan)
- Rate of Successful MRI Mode 'Turn Off' Functionality(Immediately after MRI Scan)
- Rate of Successful Interrogations and Uploads/Downloads of the Implantable Generators (IPG) Parameters(Immediately before MRI Scan)
- Rate of Successful MRI Mode 'Turn on' Functionality(Immediately before MRI Scan)
- Rate of Successful 'Turn Off' Functionality for the Stimulation(Immediately before MRI Scan)
- Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters(At 1-month follow-up)
- Rate of Successful Adjustments to the Program(Immediately before MRI Scan)
- Rate of Successful Adjustments to the Program(Immediately after MRI Scan)
- Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters(Immediately after MRI Scan)