Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform. An International, Multicenter, Prospective, and Retrospective Data Collection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 12
- 主要终点
- Rate of devices in each category of the usability scale (Likert-type scale) for each usability indicator
研究概览
简要总结
BALT has designed an electronic platform to continue collecting clinical data as part of the post-marketing clinical follow-up of its devices.
This platform is purely exploratory, without hierarchical order of the objectives and associated outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of a signed, written and dated informed consent or non-opposition (where applicable)
- •Exclusion Criteria
- •Device(s) used in multiple procedures (two, or more, pathologies treated during the same procedure)
- •Contra-indications of each device as described in the instructions for use.
排除标准
- 未提供
结局指标
主要结局
Rate of devices in each category of the usability scale (Likert-type scale) for each usability indicator
时间窗: From the procedure to 12 months post-procedure depending on the device family.
Qualitative measurement of usability for each usability indicator (i.e., good, well adapted, fairly adapted, bad). Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.
Rate of occurrence of device-specific safety indicator(s).
时间窗: From the procedure to 12 months post-procedure depending on the device family.
Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.
Rate of devices achieving its intended use.
时间窗: From the procedure to 12 months post-procedure depending on the device family.
Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.
Rate of devices achieving its specific performance indicator(s).
时间窗: From the procedure to 12 months post-procedure depending on the device family.
Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.
次要结局
未报告次要终点