A Trial of the Vidacare Powered Bone Marrow Aspiration and Core Biopsy System (OnControl by Vidacare) Compared to Traditional Manual Devices in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Percent of Hematopoietic Tissue Present in Bone Marrow Biopsy Specimens Obtained Using the Manual Device and Powered Device
研究概览
简要总结
The purpose of this study is to compare use of a powered bone marrow aspiration and biopsy device (OnControl) to use of a standard manual bone marrow aspiration and biopsy device to obtain bone marrow biopsy specimens in children. The hypothesis is that use of the powered device will improve the quantity and quality of bone marrow biopsy specimens when compared to the manual device.
详细描述
The purpose of this randomized, prospective trial is to compare use of the standard manual bone marrow aspiration and biopsy device to use of the powered bone marrow aspiration and biopsy device (OnControl) to obtain bone marrow biopsy specimens in pediatric patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent and assent for minors over the age of seven years must be obtained before any trial-related activities are initiated
- •Patients requiring bone marrow aspirations and/or biopsies as part of standard diagnosis and treatment
- •Treated at Christus Santa Rosa Children's hospital
- •Age 2 to 18 years
- •Male or female
- •Supportive family with willingness to participate in completing questionnaires
- •English or Spanish primary language
排除标准
- •Patients who are pregnant
- •Patients with hemorrhagic disorders such as congenital coagulation factor deficiencies disseminated intravascular coagulation and concomitant use of anticoagulants
- •Patients with a skin infection or recent radiation therapy at the sampling site
- •Patients with bone disorders such as osteomyelitis or osteogenesis imperfecta
结局指标
主要结局
Percent of Hematopoietic Tissue Present in Bone Marrow Biopsy Specimens Obtained Using the Manual Device and Powered Device
时间窗: within 24 hours of bone marrow sampling procedure
Bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for percent of hematopoietic tissue present. Higher percentage of hematopoietic tissue present in a biopsy specimen indicates a larger quantity of specimen for pathological evaluation.
次要结局
- Bone Marrow Biopsy Specimen Size (Width) Obtained Using the Manual Device and the Powered Device(within 24 hours of the bone marrow sampling procedure)
- Bone Marrow Biopsy Specimen Size (Length) Obtained Using the Manual Device and the Powered Device(within 24 hours of the bone marrow sampling procedure)
- Bone Marrow Biopsy Specimen Size (Volume) Obtained Using the Manual Device and the Powered Device(within 24 hours of the bone marrow sampling procedure)
- Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Aspiration Specimen Acquisition Using the Manual Device and the Powered Device(at time of the bone marrow sampling procedure)
- Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Biopsy Specimen Acquisition Using the Manual Device and the Powered Device(at time of the bone marrow sampling procedure)
- Bone Marrow Biopsy Specimen Capture Rate for the Manual Device and the Powered Device(at time of the bone marrow sampling procedure)
- Operator Satisfaction With Manual Device and Powered Device(Within 24 hours of the bone marrow sampling procedure)
- Patient Level of Post-procedural Pain Following Use of the Manual Device and the Powered Device(within 4 hours of the bone marrow sampling procedure)
研究者
Chatchawin Assanasen, MD
Associate Professor, Pediatric Hematology/Oncology
The University of Texas Health Science Center at San Antonio