Clinical Study to Evaluate the CryoBalloon™ Full Ablation System for the Ablation of Human Esophageal Epithelium in Patients Undergoing Esophagectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Safety of CryoBalloon Ablation System
研究概览
简要总结
To evaluate the safety and treatment effect of the CryoBalloon™ Full Ablation System for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy
详细描述
The primary outcomes for the study are the safety and treatment effect of the CryoBalloon™ Ablation System. An esophagectomy will be performed as scheduled following the ablation procedure; histopathological analysis of surgically-resected specimens will be performed to determine the treatment effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Up to two (2) areas of 3 cm each non-ulcerated, columnar lined esophagus or squamous linted tissue suitable for ablation
- •Older than 18 years of age at the time of consent
- •Requires a clinically-necessary esophagectomy for esophageal cancer
- •Patient has provided written informed consent using the Informed Consent Form approved by the Institution's reviewing Medical Ethics Committee (MEC)
排除标准
- •Patient refuses or is unable to provide written informed consent
- •Patient has esophageal narrowing limiting access to the intended site of ablation
研究组 & 干预措施
Single Arm
To evaluate safety and treatment effect of the CryoBalloon Ablation System for the Ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy
干预措施: CryoBalloon Ablation System (Device)
结局指标
主要结局
Safety of CryoBalloon Ablation System
时间窗: through study completion, an average of 2 weeks
Incidence of device related serious adverse events
次要结局
- Device Performance(through study completion, an average of 2 weeks)