Evaluation of a New EUS-guided Needle (ProCore) Comparing to Conventional EUS-TCB Needle (Quick-Core); A Prospective Randomized, Controlled Multi-center Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Diagnostic Accuracy.
研究概览
简要总结
The purpose of this study is to evaluate a new EUS-guided biopsy needle (ProCore®) comparing it to conventional EUS-TCB needle (Quick-Core®) in the diagnosis of your suspicious disorder.
This study needle (ProCore®) is a new EUS-guided biopsy needle and has been recently approved by the U.S. Food and Drug Administration (FDA) for use.
详细描述
Primary Objective To compare the diagnostic accuracy of new EUS histology needle (19G, ProCore, Cook Medical Inc., Winston-Salem, NC) with the conventional histology needle (19G, Quick-Core, Cook Medical Inc., Winston-Salem, NC)
Secondary Objective To compare
- The number of needle passes requiring to acquire adequate specimen
- Length of core tissue obtained
- Diagnostic contribution of immunohistochemical staining
- Rates of complications
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
- Single (Participant)
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
- •Solid tumors ≥ 2 cm in size.
排除标准
- •Thrombocytopenia
研究组 & 干预措施
EUS-Guided biopsy needle (ProCore)
Comparison of ProCore core biopsy needle to QuickCore core biopsy needle.Cook Medical core biopsy needle.
- The number of needle passes requiring to acquire adequate specimen
- Length of core tissue obtained
- Diagnostic contribution of immunohistochemical staining
- Rates of complications
干预措施: EUS-Guided biopsy needle (ProCore) (Device)
EUS-TCB needle (Quick-Core)
Comparison of core biopsy needles.
- The number of needle passes requiring to acquire adequate specimen
- Length of core tissue obtained
- Diagnostic contribution of immunohistochemical staining
- Rates of complications
干预措施: EUS-TCB needle (QuickCore) standard of care (Device)
结局指标
主要结局
Diagnostic Accuracy.
时间窗: 36 months
次要结局
- Number of Needle Passes(36 months)
- Overall Specimen Length(36 months)