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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bone Marrow Aspiration and Biopsy Specimen Collection

Intervention / Treatment
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* Device: Manual bone marrow aspiration and biopsy device
* Device: Powered bone marrow aspiration and biopsy device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manual bone marrow aspiration and biopsy procedure<br>Manual bone marrow aspiration and biopsy device | Device: Manual bone marrow aspiration and biopsy device<br>* Use of the manual bone marrow aspiration and biopsy device to collect bone marrow aspiration and bone marrow biopsy specimens.<br>|
| Active Comparator: Powered bone marrow aspiration and biopsy procedure<br>Powered bone marrow aspiration and biopsy device | Device: Powered bone marrow aspiration and biopsy device<br>* Use of the powered bone marrow aspiration and biopsy device to collect bone marrow aspiration specimens and bone marrow biopsy specimens.<br>* Other names: OnControl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Hematopoietic Tissue Present in Bone Marrow Biopsy Specimens Obtained Using the Manual Device and Powered Device | 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. | within 24 hours of bone marrow sampling procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Marrow Biopsy Specimen Size (Length) Obtained Using the Manual Device and the Powered Device | bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for length. | within 24 hours of the bone marrow sampling procedure | 
| Bone Marrow Biopsy Specimen Size (Width) Obtained Using the Manual Device and the Powered Device | bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for width. | within 24 hours of the bone marrow sampling procedure | 
| Bone Marrow Biopsy Specimen Size (Volume) Obtained Using the Manual Device and the Powered Device | bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for volume | within 24 hours of the bone marrow sampling procedure | 
| Bone Marrow Biopsy Specimen Capture Rate for the Manual Device and the Powered Device | number of needle passes required to capture one bone marrow biopsy specimen 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 Aspiration Specimen Acquisition Using the Manual Device and the Powered Device | measurement of the amount of time required to acquire a bone marrow aspiration specimen. timing starts when the bone marrow aspiration and biopsy needle first contacts the skin and ends when the aspiration specimen has been collected. | at time 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, the patient will report their level of pain post-procedure using the Wong-Baker FACES pain rating scale. The scale measures pain from 0-10, where higher numbers represent worse pain. | within 4 hours of the bone marrow sampling procedure | 
| Operator Satisfaction With Manual Device and Powered Device | Device operators will report their level of satisfaction with use of the manual device and the powered device to perform the bone marrow sampling procedure. Level of satisfaction is reported using a 0 to 10 scale, where higher numbers represent a higher level of satisfaction. | Within 24 hours 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 | measurement of the amount of time required to acquire one bone marrow biopsy specimen. timing starts when the bone marrow aspiration and biopsy needle first contacts the skin and ends when the biopsy specimen has been collected. | at time of the bone marrow sampling procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone marrow aspiration, bone marrow biopsy, OnControl, powered bone marrow aspiration and biopsy device, standard manual bone marrow aspiration and biopsy device