A Study Comparing Use of Manual and Power Bone Marrow Aspiration and Biopsy Devices in Children

A Trial of the Vidacare Powered Bone Marrow Aspiration and Core Biopsy System (OnControl by Vidacare) Compared to Traditional Manual Devices in Children

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.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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