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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Jamshidi Manual Standard Device; Device: OnControl Powered Ported Device

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78217
      • Medical Therapy and Research LLC.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Jamshidi Manual Standard Device; The Jamshidi manual standard device will be randomized for use on the right or left iliac crest	Device: Jamshidi Manual Standard Device; Jamshidi Manual Standard Device
Other: OnControl Powered Ported Device; The OnControl power ported device will be used on the opposite iliac crest	Device: OnControl Powered Ported Device; OnControl Powered Ported Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	1 Day

Collaborators and Investigators

• Sponsor: Vidacare Corporation

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: November 17, 2014
• First Submitted That Met QC Criteria: November 21, 2014
• First Posted (Estimate): November 24, 2014

Study Record Updates

• Last Update Posted (Estimate): December 7, 2016
• Last Update Submitted That Met QC Criteria: December 5, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Bone Marrow; Aspiration Procedures; To compare powered ported bone marrow aspiration procedures to manual standard bone marrow aspiration procedures
• Other Study ID Numbers: 2014-12 (Other Identifier: AP HM)