NCT06358001已完成不适用
EchoTip AcuCore Post-Market Clinical Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 8
- 主要终点
- Technical Success
研究概览
简要总结
The purpose of collecting this data is to continue to learn more about the EchoTip AcuCore and the device's ability to produce the desired favorable effect and if there are any undesired outcomes that may be related to the EchoTip AcuCore.
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
- 否
入选标准
- •Patient has been referred for an endoscopic ultrasound (EUS) fine needle biopsy procedure
- •The EchoTip AcuCore device is the first EUS biopsy needle used in the procedure.
排除标准
- •Patient's age is less than 18 years
- •Patient is unable or unwilling to sign and date the informed consent. If IRB approves a waiver of consent, this exclusion criterion is not applicable.
- •Patient is simultaneously participating in another pre-market investigational drug or pre-market investigational device study involving an EUS fine needle biopsy procedure and for which the patient has not completed the follow-up phase for the primary endpoint at least 30 days prior to enrollment in this study.
- •Inaccessible or unsuitable lesion (lesion not visualized or a large vessel, duct or primary mass interposition)
结局指标
主要结局
Technical Success
时间窗: Duration of the procedure (approx. 1 hr)
The ability to obtain a sample without failure of the needle system necessitating the use of a new needle to complete the procedure
次要结局
未报告次要终点
研究者
研究点 (8)
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