Initial Analysis of Wide-area Transepithelial Sampling for the Detection of Gastric Neoplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Diagnostic yield of the WATS approach versus standard gastric biopsy mapping
研究概览
简要总结
Potential patients will be recruited at participating sites based on routine care with clinical indications for upper endoscopy. Following informed consent, patients will undergo their scheduled endoscopy with standard forceps biopsies along with the transepithelial brush samples. All samples, biopsy and brush samples, will be sent for pathology analysis, per standard clinical practice.
详细描述
Potential patients will be recruited at participating sites based on routine care with clinical indications for upper endoscopy. Following informed consent, patients will undergo their scheduled endoscopy with standard forceps biopsies along with the transepithelial brush samples. All samples, biopsy and brush samples, will be sent for histologic analysis, with planned study of the diagnostic yields of each method.
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
- 是
入选标准
- •Subject is informed of the investigational nature of this study and given verbal and written informed consent in accordance with local, U.S., and international guidelines.
- •Both males and females at least 18 years.
- •Patients with clinical indications for upper endoscopy
排除标准
- •Patients should not have an advanced medical or psychiatric conditions which that may limit their ability to participate in the study, as judged by the physician.
结局指标
主要结局
Diagnostic yield of the WATS approach versus standard gastric biopsy mapping
时间窗: 1-3 Years
To compare the diagnostic yield of the WATS approach versus standard gastric biopsy mapping (per the updated Sydney system).
次要结局
未报告次要终点
研究者
Douglas Morgan MD
Professor of Medicine, Director, Division of Gastroenterology/ Hepatology
University of Alabama at Birmingham