A Retrospective Multicenter Investigation of the Use of the da Vinci® Surgical System in Non-Tumor Based TORS Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 285
- 试验地点
- 3
- 主要终点
- Primary Effectiveness Endpoint
研究概览
简要总结
A retrospective multicenter investigation of the use of the da Vinci® Surgical System in Non-Tumor Based TORS Procedures. The study objectives are to evaluate the safety and effectiveness of the da Vinci Surgical System in subjects undergoing Benign Non-tumor procedures.
详细描述
Primary Effectiveness Endpoint:
• Ability to complete procedure without a need for conversion to a non-robotic approach
Safety Endpoint:
Assessment of adverse events through post-operative follow-up including but not limited to:
• Bleeding
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •The specific surgical procedure involved a lingual tonsillectomy, tongue base resection, or a partial glossectomy procedure.
- •Subject was ≥18 years of age at the time of procedure
排除标准
- •Subject underwent a benign non-tumor TORS procedure that did not involve either a lingual tonsillectomy, tongue base resection or partial glossectomy.
- •Subject underwent a TORS procedure for oropharyngeal cancer
结局指标
主要结局
Primary Effectiveness Endpoint
时间窗: intra-operative
Ability to complete procedure without a need for conversion to a non-robotic approach
Primary Safety endpoint
时间窗: up to 30 days after surgery
Assessment of adverse events through post-operative follow-up including but not limited to: • Bleeding ▪ Mortality
次要结局
未报告次要终点