Cross Therapy Registry - Oedema Post Market Clinical Follow-up of Safety and Patient Outcomes for Subjects Undergoing Peroneal Nerve Stimulation by Geko™. CTR-Oedema-EU
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Performance
研究概览
简要总结
The geko™ Cross Therapy Registry - Oedema - EU (gekoTM CTR - Oedema- EU) study will prospectively and systematically collect clinical data on all device variants used in standard care pathways for edema management allowing for the monitoring of patient outcomes during a follow-up period of up to twelve months.
详细描述
The geko™ device has a wide range of clinical applications including the post- operative management of oedema.
Although many short-term acute studies have been completed using the device, little clinical data has been collected on the effect of geko™ use in current standard care pathways for oedema management on patient outcomes during follow-up of up to twelve months.
As the manufacturer of the device, Firstkind Limited has an obligation to collect safety and performance data to comply with current regulations (MDR EU 2017/745 Annex XIV, Part B). Consequently, there is a need for an observational study to provide data to demonstrate patient benefit and regulatory compliance.
The geko™ Cross Therapy Registry - Oedema -EU (gekoTM CTR - Oedema - EU) study will prospectively and systematically collect clinical data on all device variants used in standard care pathways for edema management allowing for the monitoring of patient outcomes during a follow-up period of up to twelve months. This study forms part of the overall Post-Market Clinical Follow-up strategy for the device and Post Market Surveillance (PMS) to support device and performance.
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
- •18 years and able to provide written informed consent.
- •Intact healthy skin at the site of gekoTM device application.
- •Subjects receiving gekoTM therapy as part of their standard care for oedema reduction.
排除标准
- •Pregnancy or breast feeding.
- •Use of any concurrent neuro-modulation device.
- •Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.
- •No involuntary movement of the lower leg/foot at the maximum tolerable device setting.
结局指标
主要结局
Performance
时间窗: One year
Performance: determine frequency of Device Deficiencies (DD) and compare rate to historic and published data i.e. gekoTM vs SC.
Safety: AEs and SAEs
时间窗: One year
Safety: determine frequency of adverse events (AEs) and serious AEs (SAEs) whether device related or not and compare rate to historic and published data i.e. gekoTM vs standard of care (SC).
次要结局
- Summary of Health Economic Impact(One year)
- Summary of routinely collected performance data(One Year)