HealthyNCT02299102

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

A study testing Jamshidi Manual Standard Device in people with Healthy, run by Vidacare Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 99 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Jamshidi Manual Standard Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: Dec 2014to Dec 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 99 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical Therapy and Research LLC.
San Antonio, Texas, 78217

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Healthy
Being tested: Jamshidi Manual Standard Device, OnControl Powered Ported Device
Keywords: Aspiration Procedures, Bone Marrow, powered ported bone marrow aspiration procedures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Jamshidi Manual Standard DeviceDevice
Jamshidi Manual Standard Device
OnControl Powered Ported DeviceDevice
OnControl Powered Ported Device

Study groups in NCT02299102
Study group	Role	What they receive
Group 1: First Procedure: Jamshidi Manual Standard Device	Other	The Jamshidi manual standard device procedure will be performed first. The OnControl Powered Ported device procedure will be performed second. Receives: Device: Jamshidi Manual Standard Device; Device: OnControl Powered Ported Device
Group 2: First Procedure OnControl Powered Ported Device	Other	The OnControl power ported device procedure will be performed first. The Jamshidi manual standard device procedure will be performed second. Receives: Device: Jamshidi Manual Standard Device; Device: OnControl Powered Ported Device

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
1. probably slightly dilute, particles and MK present
2. 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
1. few particles; difficult to evaluate marrow cellularity and adequacy of MK
2. good particles; adequate material to evaluate MK
3. many particles, some large, with MK easily evaluated
Clot Sections: Evaluate quantity and quality of particles 0= insufficient or no particles for interpretation
1. few small particles; difficult to determine cellularity
2. several particles, good marrow cellularity
3. numerous particles (some large); easy to assess cellularity and cell composition
Measured: 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)
1. probably slightly dilute, particles and MK present
2. 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
1. few particles; difficult to evaluate marrow cellularity and adequacy of MK
2. good particles; adequate material to evaluate MK
3. many particles, some large, with MK easily evaluated
Clot Sections: Evaluate quantity and quality of particles 0= insufficient or no particles for interpretation
1. few small particles; difficult to determine cellularity
2. several particles, good marrow cellularity
3. numerous particles (some large); easy to assess cellularity and cell composition
Measured: analyzed and results received within 30 days of Day 1 procedures

Secondary outcomes (8)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 Day, during procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2014Dec 2014

First posted24 Nov 2014 (estimated)
Study startDec 2014
Primary completionDec 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: Subject were randomized to determine which device procedure was performed first. Subjects randomized to Group 1 received the Jamshidi Manual Standard device procedure first and the OnControl Powered Ported device procedure second. Subjects ranomized to Group 2 received the OnControl Powered Ported device procedure first and the Jamshidi Manual Standard device procedure second.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02299102
Sponsor's protocol ID: 2014-12
Status last verified: Dec 2016
First submitted: 17 Nov 2014
Last updated: 29 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study Comparing Powered Ported Bone Marrow Aspiration Procedures to Manual Standard Bone Marrow Aspiration Procedures Using Healthy Volunteers
ClinicalTrials.gov ID: NCT02299102
Acronym / sponsor ID: 2014-12
Conditions: Healthy
Keywords: Aspiration Procedures, Bone Marrow, powered ported bone marrow aspiration procedures
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Vidacare CorporationIndustry (pharma, biotech, devices)
Study start: Dec 2014
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 24 Nov 2014 (estimated)
Results: Posted 29 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Subject were randomized to determine which device procedure was performed first. Subjects randomized to Group 1 received the Jamshidi Manual Standard device procedure first and the OnControl Powered Ported device procedure second. Subjects ranomized to Group 2 received the OnControl Powered Ported device procedure first and the Jamshidi Manual Standard device procedure second.

Arm	Type	Receives
Group 1: First Procedure: Jamshidi Manual Standard Device	Other	Device: Jamshidi Manual Standard Device, Device: OnControl Powered Ported DeviceThe Jamshidi manual standard device procedure will be performed first. The OnControl Powered Ported device procedure will be performed second.
Group 2: First Procedure OnControl Powered Ported Device	Other	Device: Jamshidi Manual Standard Device, Device: OnControl Powered Ported DeviceThe OnControl power ported device procedure will be performed first. The Jamshidi manual standard device procedure will be performed second.

Who may qualify

Ages: 21 to 99 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Jamshidi Manual Standard DeviceJamshidi Manual Standard Device	Device	Group 1: First Procedure: Jamshidi Manual Standard Device, Group 2: First Procedure OnControl Powered Ported Device
OnControl Powered Ported DeviceOnControl Powered Ported Device	Device	Group 1: First Procedure: Jamshidi Manual Standard Device, Group 2: First Procedure OnControl Powered Ported Device

Primary outcome

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) 1. probably slightly dilute, particles and MK present 2. 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 1. few particles; difficult to evaluate marrow cellularity and adequacy of MK 2. good particles; adequate material to evaluate MK 3. many particles, some large, with MK easily evaluated Clot Sections: Evaluate quantity and quality of particles 0= insufficient or no particles for interpretation 1. few small particles; difficult to determine cellularity 2. several particles, good marrow cellularity 3. numerous particles (some large); easy to assess cellularity and cell composition
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) 1. probably slightly dilute, particles and MK present 2. 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 1. few particles; difficult to evaluate marrow cellularity and adequacy of MK 2. good particles; adequate material to evaluate MK 3. many particles, some large, with MK easily evaluated Clot Sections: Evaluate quantity and quality of particles 0= insufficient or no particles for interpretation 1. few small particles; difficult to determine cellularity 2. several particles, good marrow cellularity 3. numerous particles (some large); easy to assess cellularity and cell composition

8 secondary outcomes

Level of Pain With Needle Insertion- Jamshidi Manual Standard Device
Time frame: Day 1 at time of procedure
Level of Pain With Needle Insertion- OnControl Power Ported Device
Time frame: Day 1 at time of procedure
Level of Pain With Aspiration - Jamshidi Manual Standard Device
Time frame: 1 Day at time of the procedure
Level of Pain With Aspiration - OnControl Power Ported Device
Time frame: 1 Day at time of the procedure
Time to Insertion - Jamshidi Manual Standard Device
Time frame: 1 Day, during procedure
Time to Insertion - OnControl Power Ported Device
Time frame: 1 Day, during procedure
Time for Aspirate Collection - Jamshidi Manual Standard Device
Time frame: 1 Day, during procedure
Time for Aspirate Collection - OnControl Power Ported Device
Time frame: 1 Day, during procedure

Results and safety

Results posted to the registry on 29 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: First Procedure Jamshidi Manual Standard Device	7	7
Group 2: First Procedure OnControl Powered Ported Device	8	8

Primary outcome: Quality of Aspirate Specimen Yield Total Score -Jamshidi Manual Standard Device

Time frame: analyzed and results received within 30 days of Day 1 procedures. Mean (Standard Deviation). Unit: units on a scale

Measure	Group 1: First Procedure Jamshidi Manual Standard Device n = 6	Group 2: Second Procedure Jamshidi Manual Standard Device n = 8
Total Score	4.83 (2.71)	5.75 (1.98)
Direct Smears/Cellularity Score	1.5 (0.84)	1.5 (0.53)
Particle Crush Smears Score	1.0 (1.1)	2.25 (1.04)
Clot Sections Score	2.8 (0.45)	2.0 (1.07)

Population analysed: One subject in Group 1 did not complete the unilateral bone marrow aspiration procedure using the Jamshidi Manual Standard Device due to the inability to insert the device into the bone marrow to complete the procedure. Therefore only 14 are included in the analysis of this outcome measure.

Primary outcome: Quality of Aspirate Specimen Yield Total Score -OnControl Power Ported Device

Time frame: analyzed and results received within 30 days of Day 1 procedures. Mean (Standard Deviation). Unit: units on a scale

Measure	Group 1: Second Procedure OnControl Powered Ported Device n = 7	Group 2: First Procedure OnControl Powered Ported Device n = 8
Total Score	6.29 (2.63)	6.25 (1.67)
Direct Smears/Cellularity Score	1.43 (0.79)	1.75 (0.46)
Particle Crush Smears Score	2.57 (0.79)	2.25 (0.89)
Clot Sections Score	2.29 (1.11)	2.25 (0.71)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: from the day of the procedure until 7 days following the procedure. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Jamshidi Manual Standard Device	0 of 15 (0%)	4 of 15 (26.7%)	0 of 15
OnControl Powered Ported Device	0 of 15 (0%)	2 of 15 (13.3%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Jamshidi Manual Standard Device in people with Healthy, run by Vidacare Corporation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02299102.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.