Bone Marrow Aspiration and Biopsy Specimen Collection
Conditions
Keywords
bone marrow aspiration, bone marrow biopsy, OnControl, powered bone marrow aspiration and biopsy device, standard manual bone marrow aspiration and biopsy device
Brief summary
The purpose of this study is to compare use of a powered bone marrow aspiration and biopsy device (OnControl) to use of a standard manual bone marrow aspiration and biopsy device to obtain bone marrow biopsy specimens in children. The hypothesis is that use of the powered device will improve the quantity and quality of bone marrow biopsy specimens when compared to the manual device.
Detailed description
The purpose of this randomized, prospective trial is to compare use of the standard manual bone marrow aspiration and biopsy device to use of the powered bone marrow aspiration and biopsy device (OnControl) to obtain bone marrow biopsy specimens in pediatric patients.
Interventions
DEVICEManual bone marrow aspiration and biopsy device
Use of the manual bone marrow aspiration and biopsy device to collect bone marrow aspiration and bone marrow biopsy specimens.
DEVICEPowered bone marrow aspiration and biopsy device
Use of the powered bone marrow aspiration and biopsy device to collect bone marrow aspiration specimens and bone marrow biopsy specimens.
Sponsors
Vidacare Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent and assent for minors over the age of seven years must be obtained before any trial-related activities are initiated * Patients requiring bone marrow aspirations and/or biopsies as part of standard diagnosis and treatment * Treated at Christus Santa Rosa Children's hospital * Age 2 to 18 years * Male or female * Supportive family with willingness to participate in completing questionnaires * English or Spanish primary language
Exclusion criteria
* Patients who are pregnant * Patients with hemorrhagic disorders such as congenital coagulation factor deficiencies disseminated intravascular coagulation and concomitant use of anticoagulants * Patients with a skin infection or recent radiation therapy at the sampling site * Patients with bone disorders such as osteomyelitis or osteogenesis imperfecta
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Hematopoietic Tissue Present in Bone Marrow Biopsy Specimens Obtained Using the Manual Device and Powered Device | within 24 hours of bone marrow sampling procedure | Bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for percent of hematopoietic tissue present. Higher percentage of hematopoietic tissue present in a biopsy specimen indicates a larger quantity of specimen for pathological evaluation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone Marrow Biopsy Specimen Size (Width) Obtained Using the Manual Device and the Powered Device | within 24 hours of the bone marrow sampling procedure | bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for width. |
| Bone Marrow Biopsy Specimen Size (Volume) Obtained Using the Manual Device and the Powered Device | within 24 hours of the bone marrow sampling procedure | bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for volume |
| Bone Marrow Biopsy Specimen Capture Rate for the Manual Device and the Powered Device | at time of the bone marrow sampling procedure | number of needle passes required to capture one bone marrow biopsy specimen using the manual device and the powered device |
| Bone Marrow Biopsy Specimen Size (Length) Obtained Using the Manual Device and the Powered Device | within 24 hours of the bone marrow sampling procedure | bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for length. |
| Patient Level of Post-procedural Pain Following Use of the Manual Device and the Powered Device | within 4 hours of the bone marrow sampling procedure | Within 4 hours of the bone marrow sampling procedure, the patient will report their level of pain post-procedure using the Wong-Baker FACES pain rating scale. The scale measures pain from 0-10, where higher numbers represent worse pain. |
| Operator Satisfaction With Manual Device and Powered Device | Within 24 hours of the bone marrow sampling procedure | Device operators will report their level of satisfaction with use of the manual device and the powered device to perform the bone marrow sampling procedure. Level of satisfaction is reported using a 0 to 10 scale, where higher numbers represent a higher level of satisfaction. |
| Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Biopsy Specimen Acquisition Using the Manual Device and the Powered Device | at time of the bone marrow sampling procedure | measurement of the amount of time required to acquire one bone marrow biopsy specimen. timing starts when the bone marrow aspiration and biopsy needle first contacts the skin and ends when the biopsy specimen has been collected. |
| Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Aspiration Specimen Acquisition Using the Manual Device and the Powered Device | at time of the bone marrow sampling procedure | measurement of the amount of time required to acquire a bone marrow aspiration specimen. timing starts when the bone marrow aspiration and biopsy needle first contacts the skin and ends when the aspiration specimen has been collected. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Manual Bone Marrow Aspiration and Biopsy Procedure Manual bone marrow aspiration and biopsy device
Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen. | 22 |
| Powered Bone Marrow Aspiration and Biopsy Procedure Powered bone marrow aspiration and biopsy device
Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen. | 22 |
| Total | 44 |
Baseline characteristics
| Characteristic | Manual Bone Marrow Aspiration and Biopsy Procedure | Powered Bone Marrow Aspiration and Biopsy Procedure | Total |
|---|---|---|---|
| Age, Continuous | 10 years STANDARD_DEVIATION 5.3 | 9.7 years STANDARD_DEVIATION 4.8 | 9.84 years STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 22 participants | 22 participants | 44 participants |
| Sex: Female, Male Female | 8 Participants | 10 Participants | 18 Participants |
| Sex: Female, Male Male | 14 Participants | 12 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
Percent of Hematopoietic Tissue Present in Bone Marrow Biopsy Specimens Obtained Using the Manual Device and Powered Device
Bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for percent of hematopoietic tissue present. Higher percentage of hematopoietic tissue present in a biopsy specimen indicates a larger quantity of specimen for pathological evaluation.
Time frame: within 24 hours of bone marrow sampling procedure
Population: All participants enrolled in the study were included in analysis, as the required sample size for the study was met. No subjects were excluded from analysis. Analysis was made per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual bone marrow aspiration and biopsy procedure | Percent of Hematopoietic Tissue Present in Bone Marrow Biopsy Specimens Obtained Using the Manual Device and Powered Device | 42.5 % Hematopoetic tissue present | Standard Deviation 21.8 |
| Powered bone marrow aspiration and biopsy procedure | Percent of Hematopoietic Tissue Present in Bone Marrow Biopsy Specimens Obtained Using the Manual Device and Powered Device | 55.8 % Hematopoetic tissue present | Standard Deviation 19.4 |
p-value: 0.03Wilcoxon (Mann-Whitney)
Secondary
Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Aspiration Specimen Acquisition Using the Manual Device and the Powered Device
measurement of the amount of time required to acquire a bone marrow aspiration specimen. timing starts when the bone marrow aspiration and biopsy needle first contacts the skin and ends when the aspiration specimen has been collected.
Time frame: at time of the bone marrow sampling procedure
Population: All participants enrolled in the study were included in the analysis as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual bone marrow aspiration and biopsy procedure | Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Aspiration Specimen Acquisition Using the Manual Device and the Powered Device | 55 seconds | Standard Deviation 34.1 |
| Powered bone marrow aspiration and biopsy procedure | Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Aspiration Specimen Acquisition Using the Manual Device and the Powered Device | 53.2 seconds | Standard Deviation 30.5 |
p-value: 0.93Wilcoxon (Mann-Whitney)
Secondary
Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Biopsy Specimen Acquisition Using the Manual Device and the Powered Device
measurement of the amount of time required to acquire one bone marrow biopsy specimen. timing starts when the bone marrow aspiration and biopsy needle first contacts the skin and ends when the biopsy specimen has been collected.
Time frame: at time of the bone marrow sampling procedure
Population: All participants enrolled in the study were included in the analysis as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual bone marrow aspiration and biopsy procedure | Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Biopsy Specimen Acquisition Using the Manual Device and the Powered Device | 252.4 seconds | Standard Deviation 95.4 |
| Powered bone marrow aspiration and biopsy procedure | Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Biopsy Specimen Acquisition Using the Manual Device and the Powered Device | 224.5 seconds | Standard Deviation 143.9 |
p-value: 0.08Wilcoxon (Mann-Whitney)
Secondary
Bone Marrow Biopsy Specimen Capture Rate for the Manual Device and the Powered Device
number of needle passes required to capture one bone marrow biopsy specimen using the manual device and the powered device
Time frame: at time of the bone marrow sampling procedure
Population: All participants enrolled in the study were included in the analysis, as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual bone marrow aspiration and biopsy procedure | Bone Marrow Biopsy Specimen Capture Rate for the Manual Device and the Powered Device | 1.1 needle passes | Standard Deviation 0.3 |
| Powered bone marrow aspiration and biopsy procedure | Bone Marrow Biopsy Specimen Capture Rate for the Manual Device and the Powered Device | 1.4 needle passes | Standard Deviation 0.7 |
p-value: 0.06Wilcoxon (Mann-Whitney)
Secondary
Bone Marrow Biopsy Specimen Size (Length) Obtained Using the Manual Device and the Powered Device
bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for length.
Time frame: within 24 hours of the bone marrow sampling procedure
Population: All participants enrolled in the study were included in the analysis, as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual bone marrow aspiration and biopsy procedure | Bone Marrow Biopsy Specimen Size (Length) Obtained Using the Manual Device and the Powered Device | 13.9 mm | Standard Deviation 3.4 |
| Powered bone marrow aspiration and biopsy procedure | Bone Marrow Biopsy Specimen Size (Length) Obtained Using the Manual Device and the Powered Device | 13.4 mm | Standard Deviation 4.7 |
p-value: 0.65Wilcoxon (Mann-Whitney)
Secondary
Bone Marrow Biopsy Specimen Size (Volume) Obtained Using the Manual Device and the Powered Device
bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for volume
Time frame: within 24 hours of the bone marrow sampling procedure
Population: All participants enrolled in the study were included in the analysis, as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual bone marrow aspiration and biopsy procedure | Bone Marrow Biopsy Specimen Size (Volume) Obtained Using the Manual Device and the Powered Device | 23.8 mm3 | Standard Deviation 11.5 |
| Powered bone marrow aspiration and biopsy procedure | Bone Marrow Biopsy Specimen Size (Volume) Obtained Using the Manual Device and the Powered Device | 36.5 mm3 | Standard Deviation 16.1 |
p-value: 0.01Wilcoxon (Mann-Whitney)
Secondary
Bone Marrow Biopsy Specimen Size (Width) Obtained Using the Manual Device and the Powered Device
bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for width.
Time frame: within 24 hours of the bone marrow sampling procedure
Population: All participants enrolled in the study were included in the analysis, as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual bone marrow aspiration and biopsy procedure | Bone Marrow Biopsy Specimen Size (Width) Obtained Using the Manual Device and the Powered Device | 1.4 mm | Standard Deviation 0.3 |
| Powered bone marrow aspiration and biopsy procedure | Bone Marrow Biopsy Specimen Size (Width) Obtained Using the Manual Device and the Powered Device | 1.8 mm | Standard Deviation 0.2 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Operator Satisfaction With Manual Device and Powered Device
Device operators will report their level of satisfaction with use of the manual device and the powered device to perform the bone marrow sampling procedure. Level of satisfaction is reported using a 0 to 10 scale, where higher numbers represent a higher level of satisfaction.
Time frame: Within 24 hours of the bone marrow sampling procedure
Population: All participants enrolled in the study were included in the analysis as the requires sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual bone marrow aspiration and biopsy procedure | Operator Satisfaction With Manual Device and Powered Device | 9 units on a scale | Standard Deviation 1 |
| Powered bone marrow aspiration and biopsy procedure | Operator Satisfaction With Manual Device and Powered Device | 9.2 units on a scale | Standard Deviation 1 |
p-value: 0.51Wilcoxon (Mann-Whitney)
Secondary
Patient Level of Post-procedural Pain Following Use of the Manual Device and the Powered Device
Within 4 hours of the bone marrow sampling procedure, the patient will report their level of pain post-procedure using the Wong-Baker FACES pain rating scale. The scale measures pain from 0-10, where higher numbers represent worse pain.
Time frame: within 4 hours of the bone marrow sampling procedure
Population: All participants enrolled in the study were included in the analysis as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual bone marrow aspiration and biopsy procedure | Patient Level of Post-procedural Pain Following Use of the Manual Device and the Powered Device | 0.27 units on a scale | Standard Deviation 0.94 |
| Powered bone marrow aspiration and biopsy procedure | Patient Level of Post-procedural Pain Following Use of the Manual Device and the Powered Device | 0.68 units on a scale | Standard Deviation 1.36 |
p-value: 0.22Wilcoxon (Mann-Whitney)