A Study Comparing Powered Ported Bone Marrow Aspiration Procedures to Manual Standard Bone Marrow Aspiration Procedures Using Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Quality of aspirate specimen yield
研究概览
简要总结
This single center study will compare the manual standard bone marrow aspiration device to the powered ported bone marrow aspiration device for use in the iliac crest in healthy adult volunteers. The study will evaluate the subjects' perceived level of pain, time to sample acquisition, and quality of specimen yield of these devices. Each subject will receive bilateral bone marrow aspiration procedures using both the manual standard and powered ported devices.
详细描述
This single center study will compare the manual standard bone marrow aspiration device to the powered ported bone marrow aspiration device for use in the posterior iliac crest of healthy adult volunteers for bone marrow aspiration specimen collection. The study will evaluate the quality of specimen yield of the devices, subject reported level of pain with needle insertion and aspiration, and time from needle/periosteum contact to needle insertion and to sample acquisition. Each subject will receive bilateral bone marrow aspiration procedures using both the manual standard and power ported needles. Subjects were randomized for which device procedure was performed first. The second procedure was performed using the other device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 21 years of age and over
- •Able to lay flat in prone position on a table for up to 1 hour
- •Self-reported as healthy, as confirmed by the investigator during the medical history review and physical examination
- •Female subjects with a negative urine pregnancy test at screening visit
排除标准
- •Reported fever within 7 days of the screening visit
- •Reported active infection within 7 days of the screening visit
- •Fever on day of study procedure
- •Signs/symptoms of active infection on day of study procedure
- •Imprisoned
- •Self identified as pregnant or lactating
- •Cognitively impaired
- •Patients with one or more conditions precluding bone marrow aspiration
- •Excessive tissue and/or absence of adequate anatomical landmarks in target bone
- •Allergy to local anesthetics
- •Unable to lay flat in prone position
- •Prothrombin time and International Normalized Ratio (PT/INR) results outside of normal range on screening lab work and deemed clinically significant by the investigator
结局指标
主要结局
Quality of aspirate specimen yield
时间窗: 30 days
Determined by a pathologist unaware of the device type used to obtain the specimen. The stained bone marrow aspirate smears will be evaluated for the presence of bone marrow particles (spicules) as well as the relative cellularity and quality of the bone marrow cells present in the smears.
次要结局
- Time from needle/periosteum contact to removal of the needle following sample acquisition(1 Day)
- Subject reported level of pain with needle insertion(1 Day)
- Subject reported level of pain with aspiration(1 Day)
- Time from needle/periosteum contact to needle insertion through the cortex(1 Day)