NCT00990782已完成不适用
CEPELA I Trial: Capsule Endoscopy for Post-Ablation Esophageal Lesion Assessment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Number of Participants With Esophageal Lesions Identified Using Capsule Endoscopy
研究概览
简要总结
This study utilizes a disposable capsule endoscope (Pillcam ESO) to assess the condition of a patient's esophagus before and after the RFA procedure, as the injury rate to the esophagus has not been established.
详细描述
Patients undergoing radiofrequency ablation (RFA) therapy for atrial fibrillation, can sometimes experience insult or injury to the esophagus, due to the proximity of the esophagus to the RFA treatment area. This study utilizes a disposable capsule endoscope (Pillcam ESO) to assess the condition of a patient's esophagus before and after the RFA procedure, as the injury rate to the esophagus has not been established.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Symptomatic patients with persistent atrial fibrillation selected for radiofrequency ablation
- •Adults aged 18 years and older
- •Patients able to give informed consent
排除标准
- •Patients under the age of 18
- •Patient unable to or unwilling to swallow the capsule endoscopes
- •Patients with cardiac pacemakers, implanted cardiac defibrillators or other implanted electro-medical devices
- •Pregnant or lactating females
- •Subjects with history of abdominal, pelvic, or bowel surgery within the past year
结局指标
主要结局
Number of Participants With Esophageal Lesions Identified Using Capsule Endoscopy
时间窗: 14 days
次要结局
- Number of Participants With Capsule-identified Esophageal Injury Who Report Symptoms Post-RFA(14 Days)
研究者
研究点 (2)
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