NCT01293448已完成不适用
Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 8
- 主要终点
- Treatment effect
研究概览
简要总结
The purpose of this study is to evaluate a cryoablation technique used to ablate human esophageal mucosa.
详细描述
The purpose of this study is to evaluate the histological results of a cryoablation technique used to ablate human esophageal mucosa. The performance and safety of the cryoablation technique will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have a minimum of 2.0 cm of non-ulcerated, non-inflammatory columnar-lined esophagus or squamous esophageal lined tissue suitable for ablation. A patient may be treated with up to 2 zones of ablation.
- •Patient is 18 to 80 years of age at the time of consent (inclusive).
- •Patient has provided written Informed Consent Form (IFC) using a form that has been approved by the Institution's reviewing IRB/EC.
- •Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements.
- •Patient's esophagectomy is clinically necessary due to reasons unrelated to this study.
- •Patient is deemed operable per standard institutional criteria.
排除标准
- •Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to IFC, post treatment instructions or follow-up guidelines.
- •Patient refuses or is unable to provide written informed consent. - -
- •Patient has or is currently undergoing endoscopic ablation therapy within 4 cm from the proposed treatment area including, but not limited to cryospray therapy, laser treatment, photodynamic therapy, multi-polar electro coagulation, endoscopic mucosal resection, radiofrequency ablation or argon plasma coagulation.
- •Patient has esophageal narrowing limiting access to the intended site of ablation.
- •Patient is undergoing or has recently undergone chemotherapy (within 15 days or WBC below normal by institutional criteria or standards).
- •Patient is undergoing or has recently undergone radiation therapy which involved the esophagus (within 15 days or WBC below normal by institutional criteria or standards).
结局指标
主要结局
Treatment effect
时间窗: Within 30 days of ablation procedure
The primary outcome measure is to evaluate the histological results (depth of injury) of a cryoballoon ablation system.
次要结局
- Post-ablation symptoms(Within 7 days of ablation procedure)
- Post procedure pain(Within 7 days of ablation procedure)
研究者
研究点 (8)
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