Evaluation of PillCam® ESO 2 in Patients With Suspected Esophageal Pathologies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 10
- 主要终点
- Accuracy parameters (sensitivity, specificity, NPV, PPV) of PillCam ESO 2 in detecting suspected Barrett's Esophagus (BE) as compared to standard EGD, using unblinded EGD as the reference standard.
研究概览
简要总结
Study Hypothesis:
- PillCam™ ESO-2 will demonstrate equivalent accuracy parameters as compared to blinded esophagogastroduodenoscopy (EGD) in detecting suspected Barrett's esophagus, detecting and grading esophagitis.
- PillCam™ ESO will demonstrate all safety parameters as compared to EGD
- PillCam™ ESO-2 will demonstrate better patient's satisfaction as compared to EGD
详细描述
Upper endoscopy (EGD) is employed to diagnose BE; however, the cost and invasiveness of this diagnostic tool limits its utilization in many patients (17). There is a need for an alternative, simple, and less invasive diagnostic tool for evaluating GERD patients and screening for BE. Esophageal capsule endoscopy (ECE) is a novel technique that offers non-invasive evaluation of esophageal pathology in gastroesophageal reflux disease (GERD) patients. The potential benefits of screening patients by Capsule Endoscopy (CE) are several. Detection of esophageal pathology during CE could select a subgroup of patients for upper endoscopy avoiding the risks and costs of an upper endoscopy in the majority. Other benefits include convenience, ability to perform the test on an outpatient basis in less than 30 minutes, patient acceptability, minimal loss of work time, safety, tolerability, the ability of non-physicians to screen patients, and potentially, improved compliance with screening recommendations. Recently, a new, high resolution capsule (ESO 2) with a larger field of view and better illumination than the previous CE has been introduced. A simplified ingestion protocol for CE that improves visualization of the Z-line has also been reported as well (17).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient age is 18 years or older
- •Patient is known or suspected to suffer from an esophageal disease based on his/her medical history and recent symptoms suggestive of GERD or BE
- •Patient agrees and signs the Informed Consent Form
- •Currently taking PPI for at least 28 days.
排除标准
- •Patient has dysphagia
- •Patient has known Zenker's Diverticulum
- •Patient is known or is suspected to suffer from esophageal and/or intestinal obstruction
- •Patient has a cardiac pacemakers or other implanted electro medical devices
- •Patient who has undergone an EGD within past seven days
- •Female patient is pregnant and/or lactating
- •Patient is expected to undergo Magnetic Resonance Imaging (MRI) examination within 7 days after ingestion of the capsule
- •Patient has had a prior pelvic or abdominal surgery of the gastrointestinal tract (other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator such as appendectomy or uncomplicated cholecystectomy)
- •Patient has any condition which precludes compliance with the study and/or device instructions
- •Patient suffers from life threatening conditions
- •Patient is currently participating in another clinical study
- •Patient is on medications that may coat the esophagus such as iron or sulcrafate.
- •Contraindication for any radiation or barium (e.g., sensitivity or allergy) required to confirm excretion of the capsule if necessary.
- •Patient is currently suffering from conditions like allergy, illness (flu) or anything else that causes congestion, excessive salivation, etc. that could foster difficulty in swallowing the capsule or affect the clarity of the CE images.
- •Contraindicated for use of laxatives, or surgery required to remove a capsule e.g., colonoscopy.
结局指标
主要结局
Accuracy parameters (sensitivity, specificity, NPV, PPV) of PillCam ESO 2 in detecting suspected Barrett's Esophagus (BE) as compared to standard EGD, using unblinded EGD as the reference standard.
时间窗: 7 days
次要结局
- Level of agreement (i.e. positive, negative and overall agreement parameters) between PillCam ESO 2 and standard EGD in classifying the Z-line following the ZAP score (Wallner et. al 2002), where Grades 0&I and grades II&III will be consolidated.(7 days)
- Subjects' satisfaction will be assessed by a post procedure questionnaire(7 days)
- Accuracy Parameters (sensitivity, specificity, NPV, PPV) of PillCam ESO 2 in detecting Esophagitis as compared to standard EGD, using unblinded EGD as the reference standard.(7 days)