NCT01312519已完成不适用
A Trial of the Vidacare Powered Bone Marrow Aspiration and Core Biopsy Systems (OnControl by Vidacare) Compared to Traditional Manual Devices
Vidacare Corporation4 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2010年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Subject Reported Level of Pain During Procedure
研究概览
简要总结
This is a randomized study evaluating use of a powered bone marrow biopsy and aspiration system (OnControl by Vidacare) compared to traditional manual devices. The hypothesis is that the powered system will reduce the level of patient pain during the aspiration and core biopsy procedures and the amount of time needed to perform the procedures.
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
- None
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
- •Adults over the age of 18
- •Patients that require core biopsy alone, or core biopsy and bone marrow aspiration
排除标准
- •Imprisoned
- •Cognitively impaired
- •Requiring english language translation other than Spanish
- •Patients with one or more conditions precluding bone marrow core biopsy
结局指标
主要结局
Subject Reported Level of Pain During Procedure
时间窗: Day 1 during the needle insertion
Subjects were asked to rate the level of pain they experienced during the procedure for needle insertion, following penetration of the cortex. A 0 to 10 pain scale was used where 0=no pain and 10= worst possible pain.
次要结局
- Time Necessary to Perform the Bone Marrow Procedure(Day 1 needle insertion through needle removal)
研究者
研究点 (4)
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