A Study Comparing Powered Ported Bone Marrow Aspiration Procedures to Manual Standard Bone Marrow Aspiration Procedures Using Healthy Volunteers

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: Jamshidi Manual Standard Device; Device: OnControl Powered Ported Device

• Registration Number: NCT02299102
• Lead Sponsor: Vidacare Corporation

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2014-11-17
• Study First Submitted QC: 2014-11-21
• Study First Posted: 2014-11-24
• Study Start: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-05
• Last Update Posted: 2016-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Adults 21 years of age and over
• Able to lay flat in prone position on a table for up to 1 hour
• Self-reported as healthy, as confirmed by the investigator during the medical history review and physical examination
• Female subjects with a negative urine pregnancy test at screening visit

Exclusion Criteria

• Reported fever within 7 days of the screening visit
• Reported active infection within 7 days of the screening visit
• Fever on day of study procedure
• Signs/symptoms of active infection on day of study procedure
• Imprisoned
• Self identified as pregnant or lactating
• Cognitively impaired
• Patients with one or more conditions precluding bone marrow aspiration
• Excessive tissue and/or absence of adequate anatomical landmarks in target bone
• Allergy to local anesthetics
• Unable to lay flat in prone position
• Prothrombin time and International Normalized Ratio (PT/INR) results outside of normal range on screening lab work and deemed clinically significant by the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Jamshidi Manual Standard Device	Jamshidi Manual Standard Device	The Jamshidi manual standard device will be randomized for use on the right or left iliac crest
OnControl Powered Ported Device	OnControl Powered Ported Device	The OnControl power ported device will be used on the opposite iliac crest

Primary Outcome Measures

Name	Time	Method
Quality of aspirate specimen yield	30 days	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.

Secondary Outcome Measures

Name	Time	Method
Time from needle/periosteum contact to removal of the needle following sample acquisition	1 Day	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.
Subject reported level of pain with needle insertion	1 Day	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.
Subject reported level of pain with aspiration	1 Day	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 from needle/periosteum contact to needle insertion through the cortex	1 Day	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.

Trial Locations

Locations (1)

Medical Therapy and Research LLC.; 🇺🇸 San Antonio, Texas, United States