NCT03489187已完成不适用
Visualase Visualization Database (VIVID-1)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 7
- 主要终点
- Image assessment
研究概览
简要总结
The purpose of the VIVID-1 data collection study is to establish a database of clinical images and associated technical files from commercial cases using the Visualase Thermal Therapy System (VTTS). All data collected will be de-identified. No safety or effectiveness assessments will be completed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient correlating with the de-identified data set to be collected received standard of care treatment using the Visualase System prior to the date of site activation.
排除标准
- •Patient correlating with the de-identified data set to be collected is a minor (less than 18 years old, or as defined by local policy) that is not allowed to participate in this type of research project (eg, IRB approval with waiver of consent) per IRB policy
- •Patient correlating with the de-identified data set to be collected is enrolled in the Medtronic SLATE trial
结局指标
主要结局
Image assessment
时间窗: During the Procedure
Identify pathologies and tissue types prescribed Visualse Thermal Therapy
次要结局
未报告次要终点
研究者
研究点 (7)
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