The TransEnterix European Patient Registry for Robotic Assisted Laparoscopic Procedures in Urology, Abdominal Surgery, Thoracic and Gynecologic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4,080
- 试验地点
- 2
- 主要终点
- Adverse Event
研究概览
简要总结
An open label observational registry trial in which participating centers enroll subjects who had or will have a laparoscopically assisted surgery using the Senhance Surgical System.
详细描述
This is a prospective multi-center registry in which sites may also choose to retrospectively enroll subjects meeting the inclusion criteria, but whom have already been treated using the Senhance system. The data collection includes baseline patient characteristics, surgical details, and adverse events. Patient follow-up time point is open to the clinical practice of each center and only adverse events are tracked post discharge.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients 18-80 years old
- •Signed the informed consent
- •life expectancy 12 months or more
排除标准
- 未提供
研究组 & 干预措施
Senhance Treated
All patients enrolled who go on to have a surgery in which the Senhance system is used
干预措施: Surgery (Device)
结局指标
主要结局
Adverse Event
时间窗: Surgery to 30 days post op
Any untoward sign symptom or disease
次要结局
未报告次要终点