Pilot Study of Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus With Low Grade and High Grade Dysplasia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification
研究概览
简要总结
The purpose of this pilot study is to provide an initial assessment of the feasibility, safety and efficacy of Polar Wand carbon dioxide cryotherapy for treatment of Barrett's low grade and high grade dysplasia by use in a small number of patients so as to support, or otherwise, the development of a full-scale trial.
详细描述
Prospective pilot study to be performed in 14 Barrett's Esophagus patients with low grade and high grade dysplasia, referred for standard of care treatment. Patients will receive treatments with carbon dioxide Polar Wand cryotherapy at 0, 2 and 4 months, followed by surveillance endoscopy with four quadrant biopsies throughout the entire Barrett's esophagus (BE)segment at 6 months, followed by endoscopy with additional treatments (if needed) at 8 and 10 months, followed by a final surveillance endoscopy at 12 months, with four quadrant biopsies throughout the entire initial BE segment length.
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 98 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred for treatment with Barrett's esophagus with dysplasia as the original indication for ablative treatment.
- •Previous fundoplication surgery is permitted
- •Age 18 years to 98 years
- •Ability to provide written, informed consent
排除标准
- •Inability to obtain biopsies due to anticoagulation, varices, etc.
- •Previous ablation therapy, wide area mucosal resection or external beam radiation to the thorax.
- •Intolerance to twice daily proton pump inhibitor medication or inability to undergo sedation or endoscopic procedures.
- •Worse than Grade B erosive esophagitis
- •Less than 3 weeks from previous endoscopy with biopsy or 6 weeks from previous endoscopic therapy (resection).
研究组 & 干预措施
Polar Wand Treatment
Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia
干预措施: Polar Wand carbon dioxide cryotherapy (Device)
结局指标
主要结局
Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification
时间窗: 12 months
The reduction of Barrett's segment length and histology classification will be measured at 12 months.
次要结局
- Reduction in Barrett's Segment Length, Using the Prague Classification(6 and 12 months)
- Assessment of Complications(12 months)
- Assessment of Post-ablation Symptoms(12 months)
- Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification(6 months)
研究者
Herbert C. Wolfsen
Professor of Medicine, Mayo College of Medicine
Mayo Clinic