Maestro 1.1 Post-Market Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 12
- 主要终点
- Adverse Events (AEs) in terms of type (device/procedure related), seriousness, level of severity. Rate of occurence of intra-procedural and post-procedural adverse events, and device related complications
研究概览
简要总结
The objective of the study is to observe the real-life usage of the Maestro Platform for surgical assistance in laparoscopic surgery.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be adults aged ≥ 18 years scheduled for laparoscopic surgery.
排除标准
- •Participants might be excluded based on the investigator's discretion.
结局指标
主要结局
Adverse Events (AEs) in terms of type (device/procedure related), seriousness, level of severity. Rate of occurence of intra-procedural and post-procedural adverse events, and device related complications
时间窗: Adverse Events (AEs) in terms of type (device/procedure related), seriousness, level of severity. Rate of occurence of intra-procedural and post-procedural adverse events, and device related complications [ Time Frame: 30 days ]
Completion of the procedure using the Maestro Platform without conversion to a manual minimally invasive or open surgical procedure specifically due to a device failure or malfunction
时间窗: During procedure
次要结局
- Incidence of procedure-specific complications(During procedure)
- Procedure duration(During procedure)
- Recovery time(30 days)
- Wheels-in Wheels-out(During procedure)
- Skin to Skin time(During procedure)
- Surgeon comfort evaluated on 1-5 scale at the end of the procedure(During procedure)
- Turnaround time(During Procedure)
- Post operative pain(1 day after the procedure)
- Camera cleaning rate(During procedure)
- Human resource utilization for surgical assistance in the operating room(During procedure)
- Surgeon satisfaction with Maestro evaluated on 1-5 scale at the end of the procedure(During procedure)
- Potential post-operative complications(30 days)
- Registry device preparation duration(During procedure)