Feasibility of Transanal Robot-Assisted Resection of Distal Colorectal Lesions Using the Medrobotics Flex® System: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Rates of complete en bloc resection
研究概览
简要总结
This clinical trial assesses the safety and effectiveness of a new device called the Flex Robotic System in the surgical removal (resection) of colorectal lesions. When an area of abnormal tissue called a lesion is found in the colon or rectum, it is often not known if the lesion is cancerous or non-cancerous. Recommendation to remove the lesion may be made. Current methods of resection can be challenging and time-consuming. The Flex Robotic System is a new device that provides a stable working environment, better ability to grasp and cut lesions, and better tissue handling when performing a resection. The Flex Robotic system may be more effective at removing colorectal lesions than standard resection techniques.
详细描述
PRIMARY OBJECTIVE:
I. To assess the rates of complete en bloc resection and adverse events of the Flex Robotic System for distal colorectal lesions.
OUTLINE:
Patients undergo resection with Flex Robotic System on study. Patients also undergo colonoscopy with or without rectal endoscopic ultrasound at screening.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 22 years (minimum age approved for use)
- •Polypoid (0-Is) and non-polypoid (0-IIa, 0-IIb and 0-IIc) lateral spreading lesions according to Paris classification
- •Colorectal lesions situated between 5 and 15 cm from the dentate line
- •Colorectal mucosal lesions ranging from 1.5 to 7 cm in maximum diameter
- •Colorectal subepithelial lesions < 2 cm in size
- •Absence of uncorrectable bleeding disorder or coagulopathy
- •Platelet count > 50,000
- •International normalized ratio (INR) < 1.5
- •Ability to give informed consent
排除标准
- •Inability to receive general anesthesia
- •Presence of medical conditions for which a transanal approach is contraindicated (e.g., anal stricture, radiation proctopathy)
- •Excavated (0-III) colorectal lesions according to Paris classification
- •Suboptimal colon preparation
- •Clinical discretion of the provider
结局指标
主要结局
Rates of complete en bloc resection
时间窗: Up to 2 years
Rates of complete en bloc resection
Incidence of adverse events
时间窗: Up to 2 years
The primary endpoint will be the Incidence of adverse events using the Flex Robotic System for distal colorectal lesions.
次要结局
未报告次要终点