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

Vidacare

Status

Completed

Conditions

Bone Marrow Aspiration and Biopsy Specimen Collection

Treatments

Device: Powered bone marrow aspiration and biopsy device

Device: Manual bone marrow aspiration and biopsy device

Study type

Interventional

Funder types

Industry

Identifiers

NCT02159118

2012

Details and patient eligibility

About

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.

Full description

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.

Enrollment

44 patients

Sex

All

Ages

2 to 18 years old

Volunteers

No Healthy Volunteers

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