NCT02159118

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 15, 2014

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 9, 2014

Completed
3 months until next milestone

Results Posted

Study results publicly available

August 25, 2014

Completed
Last Updated

January 7, 2026

Status Verified

August 1, 2014

Enrollment Period

1.1 years

First QC Date

May 15, 2014

Results QC Date

July 15, 2014

Last Update Submit

December 8, 2025

Conditions

Bone Marrow Aspiration and Biopsy Specimen Collection

Keywords

bone marrow aspirationbone marrow biopsyOnControlpowered bone marrow aspiration and biopsy devicestandard manual bone marrow aspiration and biopsy device

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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 Specimen Size (Width) Obtained Using the Manual Device and the Powered Device

    within 24 hours of the bone marrow sampling procedure

  • 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 Specimen Capture Rate for 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

    at time of the bone marrow sampling procedure

  • +3 more secondary outcomes

Study Arms (2)

Manual bone marrow aspiration and biopsy procedure

ACTIVE COMPARATOR

Manual bone marrow aspiration and biopsy device

Device: Manual bone marrow aspiration and biopsy device

Powered bone marrow aspiration and biopsy procedure

ACTIVE COMPARATOR

Powered bone marrow aspiration and biopsy device

Device: Powered bone marrow aspiration and biopsy device

Interventions

Powered bone marrow aspiration and biopsy deviceDEVICE

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

Also known as: OnControl
Powered bone marrow aspiration and biopsy procedure
Manual bone marrow aspiration and biopsy deviceDEVICE

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

Manual bone marrow aspiration and biopsy procedure

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christus Santa Rosa Children's Hospital

San Antonio, Texas, 78207, United States

Location

Results Point of Contact

Title
Chatchawin Assanasen, MD
Organization
The University of Texas Health Science Center
assanasen@uthscsa.edu
210-567-7456

Study Officials

  • Chatchawin Assanasen, MD

    Christus Santa Rosa Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Pediatric Hematology/Oncology

Study Record Dates

First Submitted

May 15, 2014

First Posted

June 9, 2014

Study Start

April 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

January 7, 2026

Results First Posted

August 25, 2014

Record last verified: 2014-08

Locations

US(1)