NCT00747448已完成不适用
CryoSpray Ablation (TM) GI Patient Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 6
- 主要终点
- Primary objectives of the study are to enable analysis of patient outcomes 2 years after final treatment and report on the effectiveness of the device in eradicating, decreasing or downgrading of the lesions.
研究概览
简要总结
The purpose of this study is to create a patient registry to collect and analyze post-510K approval information on subjects treated endoscopically with the CryoSpray Ablation™ System.
详细描述
The proposed registry is a prospective, multi-center study of patients that are being currently undergoing CryoSpray Ablation™. It will also be used to catalogue retrospective data from records of patients already treated with the device. A maximum of 40 investigational sites will participate in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
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
- •The study population consists of patients who are being treated, or were treated, with the CryoSpray Ablation™ System for malignant or pre-malignant conditions of the esophagus, including:
- •Barrett's esophagus with or without dysplasia
- •Squamous dysplasia of the esophagus
- •Esophageal cancer, any stage
排除标准
- •Subjects with esophageal lesions whose pathology was not one of the above.
- •Subjects with one of the above conditions who were not treated with the CryoSpray Ablation™ System.
结局指标
主要结局
Primary objectives of the study are to enable analysis of patient outcomes 2 years after final treatment and report on the effectiveness of the device in eradicating, decreasing or downgrading of the lesions.
时间窗: 2 years post treatment
次要结局
未报告次要终点
研究者
研究点 (6)
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