An interventional study of Jamshidi Manual Standard Device and OnControl Powered Ported Device in Healthy, sponsored by Vidacare Corporation. Completed at 1 site in United States. Open to participants aged 21 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by Vidacare Corporation · Not applicable, Interventional, and Basic science
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.
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.
Vidacare Corporation is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Device: 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 · Device: OnControl Powered Ported Device
Jamshidi Manual Standard Device
OnControl Powered Ported Device
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
Time frame: 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
Time frame: analyzed and results received within 30 days of Day 1 procedures
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 Day, during procedure
15 healthy adults were recruited to receive bilateral bone marrow aspiration procedures, one procedure using the Jamshidi Manual Standard Device and one procedure using the OnControl Powered Ported Device.
| Milestone | Group 1: First Procedure Jamshidi Manual Standard Device | Group 2: First Procedure OnControl Powered Ported Device |
|---|---|---|
| Started | 7 | 8 |
| Right iliac crest | 4 | 4 |
| Left iliac crest | 3 | 4 |
| Completed | 7 | 8 |
| Not completed | 0 | 0 |
| Milestone | Group 1: First Procedure Jamshidi Manual Standard Device | Group 2: First Procedure OnControl Powered Ported Device |
|---|---|---|
| Started | 7 | 8 |
| Right iliac crest | 3 | 4 |
| Left iliac crest | 4 | 4 |
| Completed | 7 | 8 |
| Not completed | 0 | 0 |
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
| units on a scale | Group 1: First Procedure Jamshidi Manual Standard Device | Group 2: Second Procedure Jamshidi Manual Standard Device |
|---|---|---|
| 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 |
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.
| units on a scale | Group 1: First Procedure Jamshidi Manual Standard Device | Group 2: Second Procedure Jamshidi Manual Standard Device |
|---|---|---|
| Level of Pain With Needle Insertion- Jamshidi Manual Standard Device | 2.6 ± 1.95 | 2.57 ± 2.15 |
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.
| units on a scale | Group 1: Second Procedure OnControl Powered Ported Device | Group 2: First Procedure OnControl Powered Ported Device |
|---|---|---|
| Level of Pain With Needle Insertion- OnControl Power Ported Device | 2.43 ± 2.30 | 2.38 ± 2.45 |
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.
| units on a scale | Group 1: First Procedure Jamshidi Manual Standard Device | Group 2: Second Procedure Jamshidi Manual Standard Device |
|---|---|---|
| Level of Pain With Aspiration - Jamshidi Manual Standard Device | 5.33 ± 1.03 | 5.25 ± 2.76 |
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.
| units on a scale | Group 1: Second Procedure OnControl Powered Ported Device | Group 2: First Procedure OnControl Powered Ported Device |
|---|---|---|
| Level of Pain With Aspiration - OnControl Power Ported Device | 3.86 ± 2.27 | 4.5 ± 2.78 |
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
| units on a scale | Group 1: Second Procedure OnControl Powered Ported Device | Group 2: First Procedure OnControl Powered Ported Device |
|---|---|---|
| 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 |
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
| seconds | Group 1: First Procedure Jamshidi Manual Standard Device | Group 2: Second Procedure Jamshidi Manual Standard Device |
|---|---|---|
| Time to Insertion - Jamshidi Manual Standard Device | 55.04 ± 36.72 | 79.27 ± 95.38 |
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
| seconds | Group 1: Second Procedure OnControl Powered Ported Device | Group 2: First Procedure OnControl Powered Ported Device |
|---|---|---|
| Time to Insertion - OnControl Power Ported Device | 32.63 ± 47.28 | 25.80 ± 17.90 |
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
| seconds | Group 1: First Procedure Jamshidi Manual Standard Device | Group 2: Second Procedure Jamshidi Manual Standard Device |
|---|---|---|
| Time for Aspirate Collection - Jamshidi Manual Standard Device | 75.74 ± 37.52 | 129.24 ± 152.07 |
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
| seconds | Group 1: Second Procedure OnControl Powered Ported Device | Group 2: First Procedure OnControl Powered Ported Device |
|---|---|---|
| Time for Aspirate Collection - OnControl Power Ported Device | 57.9 ± 53.06 | 48.33 ± 19.84 |
Collected over from the day of the procedure until 7 days following the procedure. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Jamshidi Manual Standard Device | 0/15 (0%) | 0/15 (0%) | 4/15 (26.7%) |
| OnControl Powered Ported Device | 0/15 (0%) | 0/15 (0%) | 2/15 (13.3%) |
| Event | Jamshidi Manual Standard Device | OnControl Powered Ported Device |
|---|---|---|
| Pain at procedure siteMusculoskeletal and connective tissue disorders | 4/15 | 2/15 |
| Age, Categorical(Participants) | Group 1: First Procedure Jamshidi Manual Standard Device | Group 2: First Procedure OnControl Powered Ported Device | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 8 | 15 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Group 1: First Procedure Jamshidi Manual Standard Device | Group 2: First Procedure OnControl Powered Ported Device | Total |
|---|---|---|---|
| Female | 6 | 2 | 8 |
| Male | 1 | 6 | 7 |
| Race and Ethnicity Not Collected(Participants) | Group 1: First Procedure Jamshidi Manual Standard Device | Group 2: First Procedure OnControl Powered Ported Device | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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