Trial Outcomes & Findings for Comparing Powered Ported Bone Marrow Aspiration to Manual Standard Bone Marrow Aspiration Procedures (NCT NCT02299102)
NCT ID: NCT02299102
Last Updated: 2026-05-29
Results Overview
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
COMPLETED
NA
15 participants
analyzed and results received within 30 days of Day 1 procedures
2026-05-29
Participant Flow
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.
All subjects received both study arms by receiving bilateral bone marrow aspiration from the iliac crest (right side and left side) using the Jamshidi manual standard device and the OnControl power ported aspiration needle device. Subjects were randomized to determine which device procedure was performed first and were assigned to Group 1 or Group 2.
Participant milestones
| Measure |
Group 1: First Procedure Jamshidi Manual Standard Device
For the first procedure, the Jamshidi manual standard device will be used to perform unilateral bone marrow aspiration from one iliac crest (left side or right side) of each subject. Whether the right or left iliac crest was used was determined by random assignment. The OnControl Powered Ported device procedure will be performed second using the other iliac crest.
|
Group 2: First Procedure OnControl Powered Ported Device
For the first procedure, the OnControl power ported device will be used to perform unilateral bone marrow aspiration from one iliac crest (left side or right side) of each subject. Whether the right or left iliac crest was used was determined by random assignment. The Jamshidi Manual Standard Device procedure will be performed second using the other iliac crest.
|
|---|---|---|
|
First Procedure
STARTED
|
7
|
8
|
|
First Procedure
Right Iliac Crest
|
4
|
4
|
|
First Procedure
Left Iliac Crest
|
3
|
4
|
|
First Procedure
COMPLETED
|
7
|
8
|
|
First Procedure
NOT COMPLETED
|
0
|
0
|
|
Second Procedure
STARTED
|
7
|
8
|
|
Second Procedure
Right Iliac Crest
|
3
|
4
|
|
Second Procedure
Left Iliac Crest
|
4
|
4
|
|
Second Procedure
COMPLETED
|
7
|
8
|
|
Second Procedure
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1: First Procedure Jamshidi Manual Standard Device
n=7 Participants
For the first procedure, the Jamshidi manual standard device will be used to perform unilateral bone marrow aspiration from one iliac crest (left side or right side) of each subject. Whether the right or left iliac crest was used was determined by random assignment. The OnControl Powered Ported device procedure will be performed second using the other iliac crest.
|
Group 2: First Procedure OnControl Powered Ported Device
n=8 Participants
For the first procedure, the OnControl power ported aspiration needle device will be used to perform unilateral bone marrow aspiration from one iliac crest (left side or right side) of each subject. Whether the right or left iliac crest was used was determined by random assignment. The Jamshidi Manual Standard Device procedure will be performed second using the other iliac crest.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=15 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=7 Participants
|
8 Participants
n=8 Participants
|
15 Participants
n=15 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=15 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=7 Participants
|
2 Participants
n=8 Participants
|
8 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=7 Participants
|
6 Participants
n=8 Participants
|
7 Participants
n=15 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: analyzed and results received within 30 days of Day 1 proceduresPopulation: 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.
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
Outcome measures
| Measure |
Group 1: Second Procedure OnControl Powered Ported Device
n=6 Participants
For Group 1, for the second procedure, the OnControl Powered Ported device will be used to perform unilateral bone marrow aspiration using the other iliac crest not used in the first procedure (left side or right side) of each subject.
|
Group 2: First Procedure OnControl Powered Ported Device
n=8 Participants
For Group 2, for the first procedure, the OnControl power ported aspiration needle device will be used to perform unilateral bone marrow aspiration from one iliac crest (left side or right side) of each subject. Whether the right or left iliac crest was used was determined by random assignment.
|
|---|---|---|
|
Quality of Aspirate Specimen Yield Total Score -Jamshidi Manual Standard Device
Total Score
|
4.83 units on a scale
Standard Deviation 2.71
|
5.75 units on a scale
Standard Deviation 1.98
|
|
Quality of Aspirate Specimen Yield Total Score -Jamshidi Manual Standard Device
Direct Smears/Cellularity Score
|
1.5 units on a scale
Standard Deviation 0.84
|
1.5 units on a scale
Standard Deviation 0.53
|
|
Quality of Aspirate Specimen Yield Total Score -Jamshidi Manual Standard Device
Particle Crush Smears Score
|
1.0 units on a scale
Standard Deviation 1.1
|
2.25 units on a scale
Standard Deviation 1.04
|
|
Quality of Aspirate Specimen Yield Total Score -Jamshidi Manual Standard Device
Clot Sections Score
|
2.8 units on a scale
Standard Deviation 0.45
|
2.0 units on a scale
Standard Deviation 1.07
|
PRIMARY outcome
Timeframe: analyzed and results received within 30 days of Day 1 proceduresThe 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
Outcome measures
| Measure |
Group 1: Second Procedure OnControl Powered Ported Device
n=7 Participants
For Group 1, for the second procedure, the OnControl Powered Ported device will be used to perform unilateral bone marrow aspiration using the other iliac crest not used in the first procedure (left side or right side) of each subject.
|
Group 2: First Procedure OnControl Powered Ported Device
n=8 Participants
For Group 2, for the first procedure, the OnControl power ported aspiration needle device will be used to perform unilateral bone marrow aspiration from one iliac crest (left side or right side) of each subject. Whether the right or left iliac crest was used was determined by random assignment.
|
|---|---|---|
|
Quality of Aspirate Specimen Yield Total Score -OnControl Power Ported Device
Total Score
|
6.29 units on a scale
Standard Deviation 2.63
|
6.25 units on a scale
Standard Deviation 1.67
|
|
Quality of Aspirate Specimen Yield Total Score -OnControl Power Ported Device
Direct Smears/Cellularity Score
|
1.43 units on a scale
Standard Deviation 0.79
|
1.75 units on a scale
Standard Deviation 0.46
|
|
Quality of Aspirate Specimen Yield Total Score -OnControl Power Ported Device
Particle Crush Smears Score
|
2.57 units on a scale
Standard Deviation 0.79
|
2.25 units on a scale
Standard Deviation 0.89
|
|
Quality of Aspirate Specimen Yield Total Score -OnControl Power Ported Device
Clot Sections Score
|
2.29 units on a scale
Standard Deviation 1.11
|
2.25 units on a scale
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: Day 1 at time of procedurePopulation: Group 1: 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; for another subject in Group 1 the pain score was not captured. Group 2: For one subject in Group 2 the pain score was not captured. Therefore only 12 are included in the analysis of this outcome measure.
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.
Outcome measures
| Measure |
Group 1: Second Procedure OnControl Powered Ported Device
n=5 Participants
For Group 1, for the second procedure, the OnControl Powered Ported device will be used to perform unilateral bone marrow aspiration using the other iliac crest not used in the first procedure (left side or right side) of each subject.
|
Group 2: First Procedure OnControl Powered Ported Device
n=7 Participants
For Group 2, for the first procedure, the OnControl power ported aspiration needle device will be used to perform unilateral bone marrow aspiration from one iliac crest (left side or right side) of each subject. Whether the right or left iliac crest was used was determined by random assignment.
|
|---|---|---|
|
Level of Pain With Needle Insertion- Jamshidi Manual Standard Device
|
2.6 units on a scale
Standard Deviation 1.95
|
2.57 units on a scale
Standard Deviation 2.15
|
SECONDARY outcome
Timeframe: Day 1 at time of procedureSubject 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.
Outcome measures
| Measure |
Group 1: Second Procedure OnControl Powered Ported Device
n=7 Participants
For Group 1, for the second procedure, the OnControl Powered Ported device will be used to perform unilateral bone marrow aspiration using the other iliac crest not used in the first procedure (left side or right side) of each subject.
|
Group 2: First Procedure OnControl Powered Ported Device
n=8 Participants
For Group 2, for the first procedure, the OnControl power ported aspiration needle device will be used to perform unilateral bone marrow aspiration from one iliac crest (left side or right side) of each subject. Whether the right or left iliac crest was used was determined by random assignment.
|
|---|---|---|
|
Level of Pain With Needle Insertion- OnControl Power Ported Device
|
2.43 units on a scale
Standard Deviation 2.30
|
2.38 units on a scale
Standard Deviation 2.45
|
SECONDARY outcome
Timeframe: 1 Day at time of the procedurePopulation: 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.
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.
Outcome measures
| Measure |
Group 1: Second Procedure OnControl Powered Ported Device
n=6 Participants
For Group 1, for the second procedure, the OnControl Powered Ported device will be used to perform unilateral bone marrow aspiration using the other iliac crest not used in the first procedure (left side or right side) of each subject.
|
Group 2: First Procedure OnControl Powered Ported Device
n=8 Participants
For Group 2, for the first procedure, the OnControl power ported aspiration needle device will be used to perform unilateral bone marrow aspiration from one iliac crest (left side or right side) of each subject. Whether the right or left iliac crest was used was determined by random assignment.
|
|---|---|---|
|
Level of Pain With Aspiration - Jamshidi Manual Standard Device
|
5.33 units on a scale
Standard Deviation 1.03
|
5.25 units on a scale
Standard Deviation 2.76
|
SECONDARY outcome
Timeframe: 1 Day at time of the procedureSubject 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.
Outcome measures
| Measure |
Group 1: Second Procedure OnControl Powered Ported Device
n=7 Participants
For Group 1, for the second procedure, the OnControl Powered Ported device will be used to perform unilateral bone marrow aspiration using the other iliac crest not used in the first procedure (left side or right side) of each subject.
|
Group 2: First Procedure OnControl Powered Ported Device
n=8 Participants
For Group 2, for the first procedure, the OnControl power ported aspiration needle device will be used to perform unilateral bone marrow aspiration from one iliac crest (left side or right side) of each subject. Whether the right or left iliac crest was used was determined by random assignment.
|
|---|---|---|
|
Level of Pain With Aspiration - OnControl Power Ported Device
|
3.86 units on a scale
Standard Deviation 2.27
|
4.5 units on a scale
Standard Deviation 2.78
|
SECONDARY outcome
Timeframe: 1 Day, during procedurePopulation: 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.
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
Outcome measures
| Measure |
Group 1: Second Procedure OnControl Powered Ported Device
n=6 Participants
For Group 1, for the second procedure, the OnControl Powered Ported device will be used to perform unilateral bone marrow aspiration using the other iliac crest not used in the first procedure (left side or right side) of each subject.
|
Group 2: First Procedure OnControl Powered Ported Device
n=8 Participants
For Group 2, for the first procedure, the OnControl power ported aspiration needle device will be used to perform unilateral bone marrow aspiration from one iliac crest (left side or right side) of each subject. Whether the right or left iliac crest was used was determined by random assignment.
|
|---|---|---|
|
Time to Insertion - Jamshidi Manual Standard Device
|
55.04 seconds
Standard Deviation 36.72
|
79.27 seconds
Standard Deviation 95.38
|
SECONDARY outcome
Timeframe: 1 Day, during procedurePopulation: For one subject in Group 2 the time to insertion was not captured. Therefore only 14 are included in the analysis of this outcome measure.
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
Outcome measures
| Measure |
Group 1: Second Procedure OnControl Powered Ported Device
n=7 Participants
For Group 1, for the second procedure, the OnControl Powered Ported device will be used to perform unilateral bone marrow aspiration using the other iliac crest not used in the first procedure (left side or right side) of each subject.
|
Group 2: First Procedure OnControl Powered Ported Device
n=7 Participants
For Group 2, for the first procedure, the OnControl power ported aspiration needle device will be used to perform unilateral bone marrow aspiration from one iliac crest (left side or right side) of each subject. Whether the right or left iliac crest was used was determined by random assignment.
|
|---|---|---|
|
Time to Insertion - OnControl Power Ported Device
|
32.63 seconds
Standard Deviation 47.28
|
25.80 seconds
Standard Deviation 17.90
|
SECONDARY outcome
Timeframe: 1 Day, during procedurePopulation: 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.
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
Outcome measures
| Measure |
Group 1: Second Procedure OnControl Powered Ported Device
n=6 Participants
For Group 1, for the second procedure, the OnControl Powered Ported device will be used to perform unilateral bone marrow aspiration using the other iliac crest not used in the first procedure (left side or right side) of each subject.
|
Group 2: First Procedure OnControl Powered Ported Device
n=8 Participants
For Group 2, for the first procedure, the OnControl power ported aspiration needle device will be used to perform unilateral bone marrow aspiration from one iliac crest (left side or right side) of each subject. Whether the right or left iliac crest was used was determined by random assignment.
|
|---|---|---|
|
Time for Aspirate Collection - Jamshidi Manual Standard Device
|
75.74 seconds
Standard Deviation 37.52
|
129.24 seconds
Standard Deviation 152.07
|
SECONDARY outcome
Timeframe: 1 Day, during procedurePopulation: For one subject in Group 2 the time for aspirate collection was not captured. Therefore only 14 are included in the analysis of this outcome measure.
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
Outcome measures
| Measure |
Group 1: Second Procedure OnControl Powered Ported Device
n=7 Participants
For Group 1, for the second procedure, the OnControl Powered Ported device will be used to perform unilateral bone marrow aspiration using the other iliac crest not used in the first procedure (left side or right side) of each subject.
|
Group 2: First Procedure OnControl Powered Ported Device
n=7 Participants
For Group 2, for the first procedure, the OnControl power ported aspiration needle device will be used to perform unilateral bone marrow aspiration from one iliac crest (left side or right side) of each subject. Whether the right or left iliac crest was used was determined by random assignment.
|
|---|---|---|
|
Time for Aspirate Collection - OnControl Power Ported Device
|
57.9 seconds
Standard Deviation 53.06
|
48.33 seconds
Standard Deviation 19.84
|
Adverse Events
Jamshidi Manual Standard Device
OnControl Powered Ported Device
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Jamshidi Manual Standard Device
n=15 participants at risk
Subjects who received the Jamshidi Manual Standard Device
|
OnControl Powered Ported Device
n=15 participants at risk
Subjects who received the OnControl Powered Ported Device.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain at procedure site
|
26.7%
4/15 • from the day of the procedure until 7 days following the procedure
Subjects were contacted by phone to ask if they have experienced any adverse events at 3 time points post-procedure: 24 hours post (+/- 8 hours), 48 hours post (+/- 8 hours), and 7 days+/- 1 day
|
13.3%
2/15 • from the day of the procedure until 7 days following the procedure
Subjects were contacted by phone to ask if they have experienced any adverse events at 3 time points post-procedure: 24 hours post (+/- 8 hours), 48 hours post (+/- 8 hours), and 7 days+/- 1 day
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place