NCT05682742进行中（未招募）不适用
A Prospective, Multicenter Clinical Investigation of the da Vinci Surgical System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 53
- 试验地点
- 8
- 主要终点
- Incidence of conversion
研究概览
简要总结
This prospective, multicenter, single-arm study is being conducted to confirm safety, effectiveness, and usability of da Vinci Surgical System in performing robotic-assisted surgical procedures.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 years or older
- •Per study Investigator's discretion, subject is a suitable candidate to undergo multiport robotic-assisted surgery for the study specified procedure as a primary procedure
- •Pre-operative
排除标准
- •Subject is pregnant or suspected to be pregnant or breastfeeding
- •Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data
- •Subject is currently participating in or has participated in a study of an investigational agent or a significant risk investigational device study within the past 6 months
- •Subject belongs to vulnerable population.
- •Subject is contraindicated for anesthesia or surgery
- •Subject has had previous neoadjuvant therapy, previous chemotherapy, immunotherapy, and/or radiation therapy for treatment of the cancer to be resected within the past 6 months
结局指标
主要结局
Incidence of conversion
时间窗: Intra-operative
Effectiveness defined as the ability to complete the planned da Vinci robotic-assisted procedures without conversion to open.
次要结局
- Incidence of adverse events(30-day follow-up)
研究者
研究点 (8)
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