NCT07800013已完成2 期
Specimen Quality and Safety of Full-core vs. Side-notch Disposable Biopsy Needles in CT-guided Percutaneous Biopsy: a Single-center Randomized Controlled Study
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Length of specimen
研究概览
简要总结
Compare the quality of samples collected by the new fully automatic full-core biopsy needle with that of existing biopsy needles, including length, weight, and debris rate
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Age: 18-80 years old
- •- Imaging suggests deep organ space-occupying lesion, requiring biopsy to confirm its nature
- •- Coagulation function is basically normal (INR≤1.5)
- •- Lesion short diameter ≥4cm
- •- Signed informed consent form.
排除标准
- •- Patients with coagulopathy who have not discontinued anticoagulant therapy
- •- Patients with severe infections or pregnancy
- •- Patients who, in the investigator's judgment, are not suitable for enrollment or have a high risk of puncture.
研究组 & 干预措施
Full Core
Experimental
干预措施: Merit Medical CorVocet full-core disposable biopsy needle (Device)
Side Notch
Active Comparator
干预措施: Bard Side notch disposable biopsy needle (Device)
结局指标
主要结局
Length of specimen
时间窗: From enrollment to the end of biopsy at 1 week
Length of specimen after biopsy, mm
Mass
时间窗: From enrollment to the end of biopsy at 1 week
Mass of specimen after biopsy, mg
次要结局
- Fragmentation(From enrollment to the end of biopsy at 1 week)
- Safty(From enrollment to the end of biopsy at 1 week)
- Incidence of Procedure-Related Adverse Events Within 7 Days Post-Biopsy(From enrollment to the end of biopsy at 1 week)
研究者
Hai Tao
Attending Physician
West China Hospital
研究点 (1)
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