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
- 1
- 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
研究组 & 干预措施
Device Feasibility (Flex Robotic System)
Patients undergo resection with Flex Robotic System on study. Patients also undergo colonoscopy with or without rectal endoscopic ultrasound at screening.
干预措施: Endoscopic Ultrasound (Procedure)
Device Feasibility (Flex Robotic System)
Patients undergo resection with Flex Robotic System on study. Patients also undergo colonoscopy with or without rectal endoscopic ultrasound at screening.
干预措施: Medical Chart Review (Other)
Device Feasibility (Flex Robotic System)
Patients undergo resection with Flex Robotic System on study. Patients also undergo colonoscopy with or without rectal endoscopic ultrasound at screening.
干预措施: Colonoscopy (Procedure)
Device Feasibility (Flex Robotic System)
Patients undergo resection with Flex Robotic System on study. Patients also undergo colonoscopy with or without rectal endoscopic ultrasound at screening.
干预措施: Medical Device Usage and Evaluation (Other)
Device Feasibility (Flex Robotic System)
Patients undergo resection with Flex Robotic System on study. Patients also undergo colonoscopy with or without rectal endoscopic ultrasound at screening.
干预措施: Resection (Procedure)
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