Wide Area Transepithelial Sample Esophageal Biopsy Combined With Computer Assisted 3-Dimensional Analysis (WATS) for the Detection of Esophageal Dysplasia: A Prospective, Randomized, Tandem Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Outcomes of patients undergoing WATS sampling. Specifically incremental yield for Barrett's Esophagus and Esophageal Dysplasia due to WATS sampling above that noted from routine forceps biopsies in various clinical settings.
研究概览
简要总结
Patients will be recruited from participating institutions prior to planned routine care EGD with WATS3D brush samples and forceps biopsies. Eligibility will be reviewed and patients who are potentially eligible for the study will be approached regarding the study. If interested, participants will be consented and proceed with routine care EGD. The study coordinator or other research personnel will document information from the routine care endoscopy as part of this research study. Follow-up information collected will include WATS3D cytology and forceps biopsy pathology results from any routine care endoscopy performed during the course of participation in the study, any surgeries received and related to their condition, and any other care received as part of their condition. WATS3D samples will be sent to CDx Diagnostics for analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Patients age: ≥ 18 years
- •Patients should have a history of Barrett's esophagus (with or without dysplasia of either indefinite, low grade or high-grade)
- •Willingness to undergo both WATS and forceps biopsies while undergoing conventional EGD with sedation
- •Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation
- •Only patients who undergo both forceps biopsies and WATS of the esophagus will be included in this study
- •Exclusion criteria:
- •Coagulopathy with an international normalized ratio above 2.0;
- •Thrombocytopenia with platelet counts below 50,000
- •History of prior esophageal ablation therapies, esophageal or gastric surgery
- •Unresolved drug or alcohol dependency
- •Pregnancy or planned pregnancy during the study period
- •Patients found to have a BE length less than 1 cm or greater than 10 cm
- •Patients with any visible lesions greater than 10 mm
排除标准
- 未提供
结局指标
主要结局
Outcomes of patients undergoing WATS sampling. Specifically incremental yield for Barrett's Esophagus and Esophageal Dysplasia due to WATS sampling above that noted from routine forceps biopsies in various clinical settings.
时间窗: up to 18 years
次要结局
未报告次要终点