Clinical Study to Evaluate the CryoBalloon™ Full and Swipe Ablation Systems for Ablation of Human Esophageal Epithelium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Safety of the CryoBalloon™ Full and Swipe Ablation System
研究概览
简要总结
This study will evaluate the C2 CryoBalloon™ Full and Swipe Ablation Systems for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy for reasons unrelated to the objective of the study
详细描述
The primary outcomes for the study are the safety and treatment effect of the C2 CryoBalloon™ Ablation System. An esophagectomy will be performed as scheduled following the ablation procedure; histopathological analysis of surgically-resected specimens will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Minimum of one 3cm area of non-ulcerated columnar-lined esophagus or squamous-lined tissue suitable for ablation
- •Older than 18 years of age
- •Requires a clinically necessary esophagectomy for esophageal cancer or other indications.
排除标准
- •Patient has esophageal narrowing limiting access to the intended sites of ablation
结局指标
主要结局
Safety of the CryoBalloon™ Full and Swipe Ablation System
时间窗: 2 weeks
Number of participants with serious, device-related adverse events after treatment with the CryoBalloon™ Swipe Ablation System
Effect of Ablation to Submucosa at Different Depth of Tissue Ablation Using the CryoBalloon™ Full and Swipe Ablation Systems
时间窗: 2 weeks
Evaluated by depth and uniformity of ablation effect in the esophagus based on histopathologic assessment. Dose response by effect of ablation to submucosa: 0: Normal 1. Inflammatory cell infiltration 2. Separation with inflammation 3. Edema and Necrosis
次要结局
- Device Performance: Average Procedure Time(Minutes from start to end of procedure)
- Device Performance: Ease of Deployment of Device(Minutes, from start to end of procedure)