Comparison of Quality of Bone Marrow Biopsy and Patient Convenience and Pain Control by a Battery Powered Drill Versus Conventional Methods in Patients With Plasma Cell Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Bone Marrow Core Biopsy Length (in mm) and Artifacts Assessed by the Pathologist
研究概览
简要总结
Since the introduction of the Jamshidi needle in 1971, new advances in bone marrow sampling have not been seen. In 2007, a new battery-powered bone marrow biopsy system was developed. This technology, using a battery-powered drill to operate the needle accessing the posterior iliac bone, was approved by the Food and Drug Administration (FDA) and is currently commercially available.
Few randomized controlled trials (RCTs) have compared the use of the battery-powered bone marrow biopsy system to the Jamshidi needle (the traditional manual) method of bone marrow sampling. This research study is designed to evaluate the effectiveness of the Jamshidi needle compared to the battery-powered bone marrow biopsy system.
100 participants will be enrolled in this study at Emory University.
详细描述
PRIMARY OBJECTIVE:
I. Assessing the quality and quantity of bone marrow core biopsies.
SECONDARY OBJECTIVES:
I. Assessing the nature of pain by established visual analogue scale (VAS) questionnaires.
II. Timing of the actual procedure.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with existing plasma cell disorders and no history of psychiatric disorders who can receive conscious sedation are eligible to participate in the trial
排除标准
- •Pregnant women are excluded from participating in this study
结局指标
主要结局
Bone Marrow Core Biopsy Length (in mm) and Artifacts Assessed by the Pathologist
时间窗: At the time of biopsy
Bone marrow biopsy length is studied with mean, median, range, and standard deviation and compared by two-sample t-test.
次要结局
- Time Taken by the Procedure Measured in Seconds Using a Stopwatch(At the time of biopsy)
- Intensity of Pain Measured Using Visual Analogue Scale (VAS) Pain Questionnaire(At the time of, 30 minutes, 1, 3, and 7 days after biopsy)
研究者
Ajay Nooka
Principal Investigator
Emory University