Skip to main content
OpenTrials
Completed

NCT Number: NCT02159118

A Study Comparing Use of Manual and Power Bone Marrow Aspiration and Biopsy 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bone Marrow Aspiration and Biopsy Specimen Collection

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Christus Santa Rosa Children's Hospital

San Antonio, Texas, 78207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual bone marrow aspiration and biopsy device

Device

Use of the manual bone marrow aspiration and biopsy device to collect bone marrow aspiration and bone marrow biopsy specimens.

Powered bone marrow aspiration and biopsy device

Device

Use of the powered bone marrow aspiration and biopsy device to collect bone marrow aspiration specimens and bone marrow biopsy specimens.

Other names: OnControl

Primary outcomes

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

    Time frame: 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 outcomes

  1. Bone Marrow Biopsy Specimen Size (Length) Obtained Using the Manual Device and the Powered Device

    Time frame: within 24 hours of the bone marrow sampling procedure

    bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for length.

  2. Bone Marrow Biopsy Specimen Size (Width) Obtained Using the Manual Device and the Powered Device

    Time frame: within 24 hours of the bone marrow sampling procedure

    bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for width.

  3. Bone Marrow Biopsy Specimen Size (Volume) Obtained Using the Manual Device and the Powered Device

    Time frame: within 24 hours of the bone marrow sampling procedure

    bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for volume

  4. Bone Marrow Biopsy Specimen Capture Rate for the Manual Device and the Powered Device

    Time frame: 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

  5. Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Aspiration Specimen Acquisition Using the Manual Device and the Powered Device

    Time frame: 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.

  6. Patient Level of Post-procedural Pain Following Use of the Manual Device and the Powered Device

    Time frame: 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.

  7. Operator Satisfaction With Manual Device and Powered Device

    Time frame: 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.

  8. Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Biopsy Specimen Acquisition Using the Manual Device and the Powered Device

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vidacare Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 9, 2014
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.