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

August 8, 2014 updated by: Chatchawin Assanasen, MD, Vidacare Corporation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78207
        • Christus Santa Rosa Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Manual bone marrow aspiration and biopsy procedure
Manual bone marrow aspiration and biopsy device
Device: Manual bone marrow aspiration and biopsy device
Use of the manual bone marrow aspiration and biopsy device to collect bone marrow aspiration and bone marrow biopsy specimens.
Active Comparator: Powered bone marrow aspiration and biopsy procedure
Powered bone marrow aspiration and biopsy device
Device: Powered bone marrow aspiration and biopsy 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

What is the study measuring?

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
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.
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
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.
within 24 hours of the bone marrow sampling procedure
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.
within 24 hours of the bone marrow sampling procedure
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
within 24 hours of the bone marrow sampling procedure
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
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
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.
at time of the bone marrow sampling procedure
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.
within 4 hours of the bone marrow sampling procedure
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.
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
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.
at time of the bone marrow sampling procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vidacare Corporation

Investigators

  • Principal Investigator: Chatchawin Assanasen, MD, Christus Santa Rosa Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

May 15, 2014

First Submitted That Met QC Criteria

June 5, 2014

First Posted (Estimate)

June 9, 2014

Study Record Updates

Last Update Posted (Estimate)

August 25, 2014

Last Update Submitted That Met QC Criteria

August 8, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012 (ANMAR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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