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Completed

NCT Number: NCT02299102

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

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.

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Key information

Conditions

Healthy

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Therapy and Research LLC.

San Antonio, Texas, 78217, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Jamshidi Manual Standard Device

Device

Jamshidi Manual Standard Device

OnControl Powered Ported Device

Device

OnControl Powered Ported Device

Primary outcomes

  1. Quality of Aspirate Specimen Yield Total Score -Jamshidi Manual Standard Device

    Time frame: analyzed and results received within 30 days of Day 1 procedures

    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

  2. Quality of Aspirate Specimen Yield Total Score -OnControl Power Ported Device

    Time frame: analyzed and results received within 30 days of Day 1 procedures

    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

Secondary outcomes

  1. Level of Pain With Needle Insertion- Jamshidi Manual Standard Device

    Time frame: Day 1 at time of procedure

    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.

  2. Level of Pain With Needle Insertion- OnControl Power Ported Device

    Time frame: Day 1 at time of procedure

    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.

  3. Level of Pain With Aspiration - Jamshidi Manual Standard Device

    Time frame: 1 Day at time of the procedure

    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.

  4. Level of Pain With Aspiration - OnControl Power Ported Device

    Time frame: 1 Day at time of the procedure

    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.

  5. Time to Insertion - Jamshidi Manual Standard Device

    Time frame: 1 Day, during procedure

    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

  6. Time to Insertion - OnControl Power Ported Device

    Time frame: 1 Day, during procedure

    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

  7. Time for Aspirate Collection - Jamshidi Manual Standard Device

    Time frame: 1 Day, during procedure

    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

  8. Time for Aspirate Collection - OnControl Power Ported Device

    Time frame: 1 Day, during procedure

    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

Sponsors and collaborators

Lead sponsor

Vidacare Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Nov 24, 2014
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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