Post Market Clinical Study to Evaluate the Performance of the Versius Surgical System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Rate of successful completion of the cholecystectomy surgical procedure without unplanned conversions to open or other minimally invasive surgery
研究概览
简要总结
The goal of this clinical trial is to learn how the Versius Surgical System, a robotic surgery device, works for gallbladder removal surgery (cholecystectomy) in adults. The main questions it aims to answer are:
How often can the surgery be successfully completed using Versius without needing to switch to a different surgical method?
What serious complications, if any, occur within 30 days after surgery?
Researchers will collect information from adult patients who have gallbladder surgery using the Versius system in U.S. hospitals. The purpose is to better understand how the device performs and how patients recover after surgery.
Participants will:
Be adults age 22 or older who are eligible for minimally invasive gallbladder surgery
Undergo robotic-assisted surgery using the Versius Surgical System
Allow the research team to collect data during surgery and up to 30 days after
Complete standard follow-up visits after discharge
Patients with certain medical conditions, such as cancer, high BMI (≥40 kg/m²), or contraindications to anesthesia or robotic surgery, will not be included in the study.
This study is sponsored by CMR Surgical Ltd., the manufacturer of the Versius system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Adult patients 22 years of age and older, eligible for soft tissue minimal access surgery, for cholecystectomy
- •Patients providing written informed consent to participate in the study
排除标准
- •Patient unwilling to provide informed consent
- •Patients undergoing surgery or treatment for malignant disease
- •Patients undergoing a concomitant surgical procedure
- •Medical contraindication for general anaesthesia or minimally invasive procedure
- •Contraindication for undergoing surgery with Versius (Bleeding diathesis, Active pregnancy or BMI ≥40 kg/m2)
研究组 & 干预措施
Robotic-Assisted Cholecystectomy Using the Versius Surgical System
干预措施: Robotic assisted cholecystectomy (Device)
结局指标
主要结局
Rate of successful completion of the cholecystectomy surgical procedure without unplanned conversions to open or other minimally invasive surgery
时间窗: From start of surgery to end of procedure
Rate of successful completion of the cholecystectomy surgical procedure without unplanned conversions to open or other minimally invasive surgery
Rate of serious adverse events up to 30 days post procedure.
时间窗: From end of surgery through 30 days post-procedure
Rate of serious adverse events up to 30 days post procedure.
Rate of successful completion of the cholecystectomy surgical procedure without unplanned conversions to open or other minimally invasive surgery
时间窗: From start of surgery to end of procedure
Rate of successful completion of the cholecystectomy surgical procedure without unplanned conversions to open or other minimally invasive surgery
Rate of serious adverse events up to 30 days post procedure.
时间窗: From end of surgery through 30 days post-procedure
Rate of serious adverse events up to 30 days post procedure.
次要结局
未报告次要终点