This single center, randomized, controlled trial will compare the manual standard bone marrow aspiration device to the powered ported bone marrow aspiration device for use in the iliac crest in healthy adult volunteers. The study will compare the subjects' perceived level of pain, time to sample acquisition, and quality of specimen yield of these devices. To serve as their own control, each subject will receive bilateral bone marrow aspiration procedures using both the manual standard and powered ported devices.
This single center, randomized, controlled trial will compare the manual standard bone marrow aspiration needle to the power ported aspiration needle for use in the posterior iliac crest of healthy volunteers for bone marrow aspiration specimen collection. The study will compare the quality of specimen yield of the devices, subject reported level of pain with needle insertion and aspiration, and time from needle/skin contact to needle insertion and to sample acquisition. Each subject will serve as his/her own control and will receive bilateral bone marrow aspiration procedures using both the manual standard and power ported needles. The order in which the devices are used for each subject's procedures and on which side each device will be used will be randomized.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
15
Jamshidi Manual Standard Device
OnControl Powered Ported Device
Medical Therapy and Research LLC.
San Antonio, Texas, United States
Quality of aspirate specimen yield
Determined by a pathologist unaware of the device type used to obtain the specimen. The stained bone marrow aspirate smears will be evaluated for the presence of bone marrow particles (spicules) as well as the relative cellularity and quality of the bone marrow cells present in the smears.
Time frame: 30 days
Subject reported level of pain with needle insertion
The secondary objective of this study is to compare the procedure of bone marrow aspiration for procedure time and subject reported level of pain when performed using the power ported and the manual standard aspiration needles.
Time frame: 1 Day
Subject reported level of pain with aspiration
The secondary objective of this study is to compare the procedure of bone marrow aspiration for procedure time and subject reported level of pain when performed using the power ported and the manual standard aspiration needles.
Time frame: 1 Day
Time from needle/periosteum contact to needle insertion through the cortex
The secondary objective of this study is to compare the procedure of bone marrow aspiration for procedure time and subject reported level of pain when performed using the power ported and the manual standard aspiration needles.
Time frame: 1 Day
Time from needle/periosteum contact to removal of the needle following sample acquisition
The secondary objective of this study is to compare the procedure of bone marrow aspiration for procedure time and subject reported level of pain when performed using the power ported and the manual standard aspiration needles.
Time frame: 1 Day
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