Healthy
Conditions
Keywords
Aspiration Procedures, Bone Marrow, powered ported bone marrow aspiration procedures
Brief summary
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.
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.
Interventions
DEVICEJamshidi Manual Standard Device
Jamshidi Manual Standard Device
DEVICEOnControl Powered Ported Device
OnControl Powered Ported Device
Sponsors
Vidacare Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Aspirate Specimen Yield Total Score -Jamshidi Manual Standard Device | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of Pain With Needle Insertion- Jamshidi Manual Standard Device | 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. |
| Level of Pain With Needle Insertion- OnControl Power Ported Device | 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. |
| Level of Pain With Aspiration - Jamshidi Manual Standard Device | 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. |
| Level of Pain With Aspiration - OnControl Power Ported Device | 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. |
| Time to Insertion - Jamshidi Manual Standard Device | 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 |
| Time to Insertion - OnControl Power Ported Device | 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 |
| Time for Aspirate Collection - Jamshidi Manual Standard Device | 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 |
| Time for Aspirate Collection - OnControl Power Ported Device | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 4 / 15 | 2 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
None listed