Outcomes of Ultrasound-guided Versus Blind Core Muscle Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Amount of Tissue Obtained
研究概览
简要总结
The objective of the proposed study is to evaluate the clinical utility of muscle ultrasonography for improving the diagnostic yield and safety of core muscle biopsy. Our facility currently uses core (needle) biopsy to obtain muscle samples in patients 18 years old or older. Currently, there is no imaging tool used to guide the actual biopsy. As muscle biopsy is an invasive and potentially painful procedure, improving the diagnostic yield of this test is important.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
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
- •Consecutive subjects scheduled for a biopsy at our EMG laboratory will be asked if they would like to participate until a total of 40 participants are obtained.
排除标准
- •Age under 18 years.
- •Inability to provide consent for participation.
结局指标
主要结局
Amount of Tissue Obtained
时间窗: At time of biopsy
This data will be analyzed to determine if ultrasound guidance improves muscle yield (as measured by pathology determined volume and mass).
Number of Patients Receiving Diagnosis From Muscle Biopsy
时间窗: At time of biopsy
The rate of achieving a specific final diagnosis in ultrasound guided muscle biopsies vs. unguided biopsies will be examined.
次要结局
- Number of Participants With Adverse Events Related to Muscle Biopsy(Patient involvement limited to the time of biopsy; Records analyzed up to 10 months after biopsy)
- Number of Times Biopsy Needle Was Inserted to Obtain Biopsy Tissue(At time of biopsy)
- Number of Participants With Inadequate Biopsy Samples(At time of pathology review)