Phase II Study of the Da Vinci Single Port (SP) Robotic System for Abdominal and Pelvic Procedures
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Incidence of major surgical complications
研究概览
简要总结
This phase II trial test the effectiveness and safety of a single-port robotic device (the da Vinci single port [SP]1098) for use in abdominal and pelvic surgeries. The da Vinci SP1098 robotic device can be used to perform less invasive surgeries that allow entry into the body through a single, small incision. The use of this device during surgery may allow surgeons to perform complex procedures that result in less pain, fewer complications and side effects, and improved recovery.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the effectiveness and safety for abdominal and pelvic procedures of a single-port robotic device (da Vinci SP1098) that is Food and Drug Administration (FDA)-approved for other indications, specifically urological and transoral otolaryngology surgical procedures.
OUTLINE:
Patients undergo surgery using the da Vinci SP1098 robotic system on study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Documented informed consent of the participant and/or legally authorized representative
- •Any patient scheduled to undergo robot-assisted abdominal or pelvic procedures
- •Age > 18 years
排除标准
- •Body mass index (BMI) > 45
- •Contraindications to minimally invasive surgery including chronic obstructive pulmonary disorders
- •Past history of failed attempt of minimally invasive abdominal or pelvic surgery
研究组 & 干预措施
Device feasibility (da Vinci SP1098 robotic system)
Patients undergo surgery using the da Vinci SP1098 robotic system on study.
干预措施: Robot-Assisted Surgery (Device)
结局指标
主要结局
Incidence of major surgical complications
时间窗: Within 30 days of operation
Will be assessed by Clavien-Dindo classification as grade 3 or higher. The number and frequency will be reported with 95% confidence intervals.
Conversion of operation to laparotomy
时间窗: Within 30 days of operation
The number and frequency will be reported with 95% confidence intervals.
次要结局
未报告次要终点