A Multicenter, Single-Arm Study of the Efficacy of EsoGuard(TM) on Samples Collected Using EsoCheck(TM) Versus Esophagogastroduodenoscopy for the Diagnosis of Barrett's Esophagus in an At-Risk Screening Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 28
- 主要终点
- Primary Efficacy
研究概览
简要总结
The study will assess the performance of the combined system, i.e., the use of the EsoGuard assay on cells collected using the EsoCheck 510(k) cleared device, to detect Barrett's Esophagus, with and without dysplasia, and/or Esophageal Adenocarcinoma, in individuals deemed to be at high risk for these conditions (i.e., screening) per ACG guidelines.
详细描述
This is a multicenter, single-arm study designed to assess the operating characteristics of the EsoGuard diagnostic assay performed on distal esophageal mucosal cells collected using the EsoCheck cell collection device, compared to the gold standard, for the screening of BE with and without dysplasia and for esophageal adenocarcinoma (EAC), in patients at high risk for BE and for whom a screening EGD is indicated according to ACG-established criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men aged 50 years old and older
- •≥5 years either of
- •GERD symptoms,
- •GERD treated with proton pump inhibitor (PPI) therapy (whether symptom control is achieved or not), or,
- •any combination of treated and untreated periods, as long the cumulative total is at least 5 years
- •No solid foods eaten for at least 2 hours prior to EsoCheck procedure
- •One or more of the following risk factors:
- •Caucasian race
- •Current or past history of cigarette smoking
- •BMI of at least 30 kg/m2
- •First-degree relative with BE or EAC
排除标准
- •History of prior EGD procedure
- •Inability to provide written informed consent
- •On anti-coagulant drug(s) that cannot be temporarily discontinued
- •Known history of esophageal varices or esophageal stricture
- •Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGD procedure, and/or having biopsies taken, including but not limited to due to comorbidities such as coagulopathy or a known history of esophageal diverticula, esophageal fistula and/or esophageal ulceration
- •History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
- •Oropharyngeal tumor
- •History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication procedure
- •History of myocardial infarction or cerebrovascular accident within past 6 months
- •History of esophageal motility disorder
- •Currently implanted Linx device
结局指标
主要结局
Primary Efficacy
时间窗: Cross-sectional point in time per subject through study completion which is up to approximately 5 weeks
The sensitivity and specificity of EsoGuard for the diagnosis of BE on samples collected using EsoCheck, wherein the definitive diagnosis of BE is made by concomitant EGD and biopsy.
次要结局
- Secondary Efficacy(Cross-sectional point in time per subject through study completion which is up to approximately 5 weeks)