Evaluation of Patients With Non-cardiac Chest Pain Using PillCam Eso - a Wireless Imaging Capsule of the Esophagus.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- endoscopy for evaluating the prevalence of esophago-gastric lesions in patients
研究概览
简要总结
The purpose of this study is to find out how common diseases of the esophagus can cause chest pain. Gastroesophageal reflux disease (GERD), commonly known as heartburn, is a common cause of chest pain in patients that do not have heart problems. The study test is called PillCam Eso, it is a small, pill sized capsule that has a small camera inside it. The camera will take pictures of the esophagus and the stomach as it goes down. Findings of the PillCam Eso will be compared to findings during conventional upper endoscopy.
详细描述
Non-cardiac chest pain (NCCP) is defined by recurrent episodes of retrosternal chest pain in the absence of significant cardiovascular disease after a thorough cardiac evaluation. It accounts for 2-5% of all emergency department visits. Studies examining the prevalence of esophago-gastric lesions in patients with NCCP referred to gastroenterologists have found esophagitis, esophageal ulcers, hiatal hernias, gastritis, and gastric ulcers in 62% of patients. Advances in endoscopic technologies, particularly, the introduction of the wireless video-capsule (PillCam Eso) allows for the possibility of direct visualization of the upper gastrointestinal tract in the emergency department. During capsule endoscopy, a patient will swallow a pill-sized video-capsule, the wireless images of the gastrointestinal tract are transmitted to a computer. Findings of the PillCam Eso will be then compared to findings during conventional upper endoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 to 80 years
- •negative cardiac evaluation in the emergency department
- •pre-established access to a primary care provider
- •ability to give informed consent
排除标准
- •known history of ischemic heart disease
- •proton pump inhibitor therapy
- •known or suspected obstructions or strictures in the gastrointestinal tract, including a history of Crohn's disease, gastrointestinal surgery other than cholecystectomy or appendectomy.
- •permanent pacemakers/defibrillators or other implantable wireless devices
- •known pregnancy
- •unstable medical conditions
- •inability to follow instructions
- •active psychiatric conditions that preclude participation in the study
结局指标
主要结局
endoscopy for evaluating the prevalence of esophago-gastric lesions in patients
时间窗: 60 day
次要结局
未报告次要终点