| 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. | 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. | Posted | | Mean | Standard Deviation | % Hematopoetic tissue present | | within 24 hours of bone marrow sampling procedure | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00042.5± 21.8
- OG00155.8± 19.4
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Wilcoxon (Mann-Whitney) | | 0.03 | | | | | | | | | | | | | | Superiority or Other | | |
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| 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. | 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. | Posted | | Mean | Standard Deviation | mm | | within 24 hours of the bone marrow sampling procedure | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | mm | | within 24 hours of the bone marrow sampling procedure | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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 | 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. | Posted | | Mean | Standard Deviation | mm3 | | within 24 hours of the bone marrow sampling procedure | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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 | 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. | Posted | | Mean | Standard Deviation | needle passes | | at time of the bone marrow sampling procedure | needle passes | needle passes | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | seconds | | at time of the bone marrow sampling procedure | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | within 4 hours of the bone marrow sampling procedure | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Within 24 hours of the bone marrow sampling procedure | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | seconds | | at time of the bone marrow sampling procedure | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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