Clinical trial NCT02159118: A Study Comparing Use of Manual and Power Bone Marrow Aspiration and Biopsy Devices in Children
Official title: A Trial of the Vidacare Powered Bone Marrow Aspiration and Core Biopsy System (OnControl by Vidacare) Compared to Traditional Manual Devices in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Marrow Aspiration and Biopsy Specimen Collection
Keywords: bone marrow aspiration
bone marrow biopsy
OnControl
powered bone marrow aspiration and biopsy device
standard manual bone marrow aspiration and biopsy device
Lead sponsor: Vidacare Corporation
Sponsor class: INDUSTRY
First posted: 2014-06-09
Enrollment: 44
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of Hematopoietic Tissue Present in Bone Marrow Biopsy Specimens Obtained Using the Manual Device and Powered Device
timeFrame: within 24 hours of bone marrow sampling procedure
Secondary outcomes:
measure: Bone Marrow Biopsy Specimen Size (Length) Obtained Using the Manual Device and the Powered Device
timeFrame: within 24 hours of the bone marrow sampling procedure
measure: Bone Marrow Biopsy Specimen Size (Width) Obtained Using the Manual Device and the Powered Device
timeFrame: within 24 hours of the bone marrow sampling procedure
measure: Bone Marrow Biopsy Specimen Size (Volume) Obtained Using the Manual Device and the Powered Device
timeFrame: within 24 hours of the bone marrow sampling procedure
measure: Bone Marrow Biopsy Specimen Capture Rate for the Manual Device and the Powered Device
timeFrame: at time of the bone marrow sampling procedure
measure: Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Aspiration Specimen Acquisition Using the Manual Device and the Powered Device
timeFrame: at time of the bone marrow sampling procedure
measure: Patient Level of Post-procedural Pain Following Use of the Manual Device and the Powered Device
timeFrame: within 4 hours of the bone marrow sampling procedure
measure: Operator Satisfaction With Manual Device and Powered Device
timeFrame: Within 24 hours of the bone marrow sampling procedure
measure: Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Biopsy Specimen Acquisition Using the Manual Device and the Powered Device
timeFrame: at time of the bone marrow sampling procedure
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Christus Santa Rosa Children's Hospital
state: Texas
Study officials:
affiliation: Christus Santa Rosa Children's Hospital
name: Chatchawin Assanasen, MD
role: PRINCIPAL_INVESTIGATOR
References: