Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Epithelium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Number of Participants With Complete Eradication of Esophageal Dysplasia
研究概览
简要总结
Assess Cryoablation (CryoBalloon Ablation cryotherapy) for treatment of Dysplastic Barrett's Esophagus, Esophageal Squamous Dysplasia and early Esophageal Cancer. The cryoablation treatment will be offered as an alternative to standard ablation therapies such as Radiofrequency Ablation, Argon Plasma Coagulation and carbon dioxide Cryotherapy).
详细描述
Cryoablation (cryotherapy) is an established type of mucosal ablation for treatment of various conditions in the GI tract, including Barrett's esophagus and esophageal cancer. The purpose of this study is to assess the safety, feasibility and performance of cryoablation system (the C2 Focal Cryoablation Device in patients with BE and esophageal squamous dysplasia who need ablation therapy for clinical standard care. The new cryoablation treatment will be offered as an alternative to standard ablation therapies already in place (radiofrequency ablation, carbon dioxide cryotherapy).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients recommended for ablation of either Barrett's esophagus with dysplasia or esophageal squamous dysplasia, scheduled for upper endoscopy.
排除标准
- •Patient unable to undergo endoscopy,
- •Patients with visible esophageal mass.
结局指标
主要结局
Number of Participants With Complete Eradication of Esophageal Dysplasia
时间窗: 12 months
Evaluate histopathology of esophageal tissue for absence of Barrett's esophagus or squamous dysplasia after cryoablation treatments (assess for complete eradication of dysplasia).
Treatment-related Adverse Events Assessed by Pain Scale
时间窗: 1 day post treatment (day 2), 1 week post treatment (day 8), and 1 month (day 31)
Evaluate by patient questionnaire for pain on an 11-point scale. The 11-point Likert scale represents a range of discomfort or pain from 0 (no pain) to 10 (extreme pain), which individuals indicate their level of discomfort or pain. Higher score more discomfort. Each subject is evaluated for post-treatment pain after each cryoablation session. Subjects may have a different number of treatment sessions depending on the extent of disease.
Treatment-related Adverse Events Assessed by Stricture Rate
时间窗: Up to 12 months
Number of patients with esophageal strictures requiring dilation. Patients reporting dysphagia with solid food, with balloon dilations from index visit to 12 months.
Number of Participants With Complete Eradication of Esophageal Dysplasia
时间窗: 12 months
Evaluate histopathology of esophageal tissue for absence of Barrett's esophagus or squamous dysplasia after cryoablation treatments (assess for complete eradication of dysplasia).
Treatment-related Adverse Events Assessed by Pain Scale
时间窗: 1 day post treatment (day 2), 1 week post treatment (day 8), and 1 month (day 31)
Evaluate by patient questionnaire for pain on an 11-point scale. The 11-point Likert scale represents a range of discomfort or pain from 0 (no pain) to 10 (extreme pain), which individuals indicate their level of discomfort or pain. Higher score more discomfort. Each subject is evaluated for post-treatment pain after each cryoablation session. Subjects may have a different number of treatment sessions depending on the extent of disease.
Treatment-related Adverse Events Assessed by Stricture Rate
时间窗: Up to 12 months
Number of patients with esophageal strictures requiring dilation. Patients reporting dysphagia with solid food, with balloon dilations from index visit to 12 months.
次要结局
- Number of Participants With Complete Eradication of Intestinal Metaplasia(12 months)
- Number of Participants With Complete Eradication of Intestinal Metaplasia(12 months)