Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-03-01 @ 3:16 AM
Study NCT ID:
NCT02159118
Status:
COMPLETED
Last Update Posted:
2014-08-25
First Post:
2014-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Comparing Use of Manual and Power Bone Marrow Aspiration and Biopsy Devices in Children
Sponsor:
Vidacare Corporation
Organization:
Study Overview
Official Title:
A Trial of the Vidacare Powered Bone Marrow Aspiration and Core Biopsy System (OnControl by Vidacare) Compared to Traditional Manual Devices in Children
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: