NCT03011229撤回不适用
Endoscopic Ultrasound Fine Needle Biopsy of Submucosal Lesions of the GI Tract; Finding the Right Needle - A Randomized Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- diagnostic accuracy of biopsy needle
研究概览
简要总结
The purpose of this study is to compare the diagnostic accuracy of a novel endoscopic ultrasound (EUS) biopsy needle to the current standard EUS needle.
The investigators hypothesize that with the SharkcoreTM needle a diagnostic yield of 90% is possible for subepithelial lesions (SEL) within the Gastrointestinal (GI) tract versus 60% yield with the current needle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
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 or older referred for EUS found to have a hypoechoic lesion > 8 mm within the GI lumen arising from the muscularis propria, as determined by EUS.
- •Women that have a negative pregnant test
排除标准
- •Patients under the age of
- •Uncorrectable coagulopathy (INR>1.5)
- •Uncorrectable thrombocytopenia (platelet count <50,000)
- •Patient who is unable to comply with study requirements
- •Pregnant women
- •Female patients who are not tested per our current unit protocol
- •Refusal to consent or unable to provide informed consent
结局指标
主要结局
diagnostic accuracy of biopsy needle
时间窗: end of biopsy, approximately 10 minutes
次要结局
未报告次要终点
研究者
研究点 (2)
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