Comparing Powered Ported Bone Marrow Aspiration to Manual Standard Bone Marrow Aspiration Procedures

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

This single center study 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 evaluate the subjects' perceived level of pain, time to sample acquisition, and quality of specimen yield of these devices. 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 study will compare the manual standard bone marrow aspiration device to the powered ported bone marrow aspiration device for use in the posterior iliac crest of healthy adult volunteers for bone marrow aspiration specimen collection. The study will evaluate the quality of specimen yield of the devices, subject reported level of pain with needle insertion and aspiration, and time from needle/periosteum contact to needle insertion and to sample acquisition. Each subject will receive bilateral bone marrow aspiration procedures using both the manual standard and power ported needles. Subjects were randomized for which device procedure was performed first. The second procedure was performed using the other device.

• 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

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: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1: First Procedure: Jamshidi Manual Standard Device; The Jamshidi manual standard device procedure will be performed first. The OnControl Powered Ported device procedure will be performed second.	Device: Jamshidi Manual Standard Device; Jamshidi Manual Standard Device; Device: OnControl Powered Ported Device; OnControl Powered Ported Device
Other: Group 2: First Procedure OnControl Powered Ported Device; The OnControl power ported device procedure will be performed first. The Jamshidi manual standard device procedure will be performed second.	Device: Jamshidi Manual Standard Device; Jamshidi Manual Standard Device; 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 Total Score -Jamshidi Manual Standard Device	The Quality of Aspirate Specimen Yield Total Score is a sum score using the 3 quality rating scales below. The Score range: 0 to 8; Higher scores mean greater quality. Direct Smears- Cellularity: 0= obviously dilute, no good particles or adequate megakaryocytes (MK); probably slightly dilute, particles and MK present; cellular, good particles; MK present on edge, smears reflect clot section cellularity Particle Crush Smears: Evaluate presence of particles and quality of cellularity: 0= no particles; few particles; difficult to evaluate marrow cellularity and adequacy of MK; good particles; adequate material to evaluate MK; many particles, some large, with MK easily evaluated Clot Sections: Evaluate quantity and quality of particles 0= insufficient or no particles for interpretation; few small particles; difficult to determine cellularity; several particles, good marrow cellularity; numerous particles (some large); easy to assess cellularity and cell composition	analyzed and results received within 30 days of Day 1 procedures
Quality of Aspirate Specimen Yield Total Score -OnControl Power Ported Device	The Quality of Aspirate Specimen Yield Total Score is a sum score using the 3 quality rating scales below. The Score range: 0 to 8; Higher scores mean greater quality. Direct Smears- Cellularity: 0= obviously dilute, no good particles or adequate megakaryocytes (MK); probably slightly dilute, particles and MK present; cellular, good particles; MK present on edge, smears reflect clot section cellularity Particle Crush Smears: Evaluate presence of particles and quality of cellularity: 0= no particles; few particles; difficult to evaluate marrow cellularity and adequacy of MK; good particles; adequate material to evaluate MK; many particles, some large, with MK easily evaluated Clot Sections: Evaluate quantity and quality of particles 0= insufficient or no particles for interpretation; few small particles; difficult to determine cellularity; several particles, good marrow cellularity; numerous particles (some large); easy to assess cellularity and cell composition	analyzed and results received within 30 days of Day 1 procedures

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Pain With Needle Insertion- Jamshidi Manual Standard Device	Subject reported level of pain with needle insertion (insertion of the bone marrow aspiration device, OnControl or Jamshidi, into the bone marrow space of the iliac crest) was reported by the patients for each procedure performed using the Wong-Baker FACES Pain Rating Scale Where 0 = no hurt and 10 = hurts worst. Higher numbers indicate greater pain.	Day 1 at time of procedure
Level of Pain With Needle Insertion- OnControl Power Ported Device	Subject reported level of pain with needle insertion (insertion of the bone marrow aspiration device, OnControl or Jamshidi, into the bone marrow space of the iliac crest) was reported by the patients for each procedure performed using the Wong-Baker FACES Pain Rating Scale Where 0 = no hurt and 10 = hurts worst. Higher numbers indicate greater pain.	Day 1 at time of procedure
Level of Pain With Aspiration - Jamshidi Manual Standard Device	Subject reported level of pain with aspiration (withdrawing the bone marrow aspirate specimen with syringe) was reported by the patients for each procedure performed using the Wong-Baker FACES Pain Rating Scale Where 0 = no hurt and 10 = hurts worst. Higher numbers indicate greater pain.	1 Day at time of the procedure
Level of Pain With Aspiration - OnControl Power Ported Device	Subject reported level of pain with aspiration (withdrawing the bone marrow aspirate specimen with syringe) was reported by the patients for each procedure performed using the Wong-Baker FACES Pain Rating Scale Where 0 = no hurt and 10 = hurts worst. Higher numbers indicate greater pain.	1 Day at time of the procedure
Time to Insertion - Jamshidi Manual Standard Device	Time recorded in seconds from contact of the device and the periosteum of the iliac crest to insertion of the needle through the cortex into the medullary space	1 Day, during procedure
Time to Insertion - OnControl Power Ported Device	Time recorded in seconds from contact of the device and the periosteum of the iliac crest to insertion of the needle through the cortex into the medullary space	1 Day, during procedure
Time for Aspirate Collection - Jamshidi Manual Standard Device	Time recorded in seconds from contact of the device and the periosteum of the iliac crest to removal of the needle from the medullary cavity following aspirate sample acquisition	1 Day, during procedure
Time for Aspirate Collection - OnControl Power Ported Device	Time recorded in seconds from contact of the device and the periosteum of the iliac crest to removal of the needle from the medullary cavity following aspirate sample acquisition	1 Day, during procedure

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 (Estimated): November 24, 2014

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: December 1, 2016

More Information

Terms related to this study

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