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

Not Applicable

Completed

• Conditions: Bone Marrow Aspiration and Biopsy Specimen Collection
• Interventions: Device: Manual bone marrow aspiration and biopsy device; Device: Powered bone marrow aspiration and biopsy device

• Registration Number: NCT02159118
• Lead Sponsor: Vidacare Corporation

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.

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Study First Submitted: 2014-05-15
• Study First Submitted QC: 2014-06-05
• Study First Posted: 2014-06-09
• Results First Submitted: 2014-07-15
• Status Verified: 2014-08
• Results First Submitted QC: 2014-08-08
• Last Update Submitted: 2014-08-08
• Results First Posted: 2014-08-25
• Last Update Posted: 2014-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual bone marrow aspiration and biopsy procedure	Manual bone marrow aspiration and biopsy device	Manual bone marrow aspiration and biopsy device
Powered bone marrow aspiration and biopsy procedure	Powered bone marrow aspiration and biopsy device	Powered bone marrow aspiration and biopsy device

Primary Outcome Measures

Name	Time	Method
Percent of Hematopoietic Tissue Present in Bone Marrow Biopsy Specimens Obtained Using the Manual Device and Powered Device	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.

Secondary Outcome Measures

Name	Time	Method
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 specimens will be evaluated by a blinded pathologist and measured for width.
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 specimens will be evaluated by a blinded pathologist and measured for length.
Bone Marrow Biopsy Specimen Size (Volume) Obtained Using the Manual Device and the Powered Device	within 24 hours of the bone marrow sampling procedure	bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for volume
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	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.
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	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.
Bone Marrow Biopsy Specimen Capture Rate for the Manual Device and the Powered Device	at time of the bone marrow sampling procedure	number of needle passes required to capture one bone marrow biopsy specimen using the manual device and the powered device
Operator Satisfaction With Manual Device and Powered Device	Within 24 hours of the bone marrow sampling procedure	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.
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	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.

Trial Locations

Locations (1)

Christus Santa Rosa Children's Hospital; 🇺🇸 San Antonio, Texas, United States