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Procedure

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

N/A
Waitlist Available
Led By Chatchawin Assanasen, MD
Research Sponsored by Vidacare Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 24 hours of bone marrow sampling procedure
Awards & highlights
No Placebo-Only Group

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time of the bone marrow sampling procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of the bone marrow sampling procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent of Hematopoietic Tissue Present in Bone Marrow Biopsy Specimens Obtained Using the Manual Device and Powered Device
Secondary study objectives
Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Aspiration Specimen Acquisition Using the Manual Device and the Powered Device
Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Biopsy Specimen Acquisition Using the Manual Device and the Powered Device
Bone Marrow Biopsy Specimen Capture Rate for the Manual Device and the Powered Device
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Manual bone marrow aspiration and biopsy procedureActive Control1 Intervention
Manual bone marrow aspiration and biopsy device
Group II: Powered bone marrow aspiration and biopsy procedureActive Control1 Intervention
Powered bone marrow aspiration and biopsy device

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Who is running the clinical trial?

Vidacare CorporationLead Sponsor
15 Previous Clinical Trials
468 Total Patients Enrolled
Chatchawin Assanasen, MDPrincipal InvestigatorChristus Santa Rosa Children's Hospital
~3 spots leftby Jan 2026
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