NCT06030180已完成不适用
CLUE: CLinical Utility Study of EsoGuard on Samples Collected Using EsoCheck as a Triage Test for Endoscopy to Identify Barrett's Esophagus (BE)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 566
- 试验地点
- 8
- 主要终点
- Clinical Utility
研究概览
简要总结
Utilize real-world data from the commercial use of EsoGuard testing on samples collected with EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's decision for endoscopy referral. Assess patient compliance with recommendations for upper endoscopy, and relationship of compliance to positive EsoGuard results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals in whom the clinical decision has been made to screen for BE using EC/EG
- •Individuals who meet criteria for BE screening in accordance with either the 2022 ACG guidelines, or the AGA best practice advice from their 2022 clinical practice update.
排除标准
- •Individuals who fall outside the eligible population defined by the EsoCheck device Instructions For Use (IFU)
- •Individuals who do not meet either the ACG or AGA guidelines/practice advice for BE screening
- •Inability to provide written informed consent or participate in the required follow up
研究组 & 干预措施
Single Arm Study
Other
干预措施: EsoGuard (Device)
结局指标
主要结局
Clinical Utility
时间窗: Through study completion, an average of 1 year
Utilize real-world data from the commercial use of EsoGuard testing on samples collected with EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's decision for endoscopy referral. This will be measured by asking physicians how the EsoGuard result impacted their referral decision.
次要结局
- Patient Compliance(Through study completion, an average of 1 year)
研究者
研究点 (8)
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