Bone Marrow Biopsy Procedures
Conditions
Keywords
Bone marrow biopsy of iliac crest
Brief summary
This is a randomized study evaluating use of a powered bone marrow biopsy and aspiration system (OnControl by Vidacare) compared to traditional manual devices. The hypothesis is that the powered system will reduce the level of patient pain during the aspiration and core biopsy procedures and the amount of time needed to perform the procedures.
Interventions
DEVICEOnControl Bone Marrow Biopsy and Aspiration System
Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest for the purpose of aspiration and core biopsy collection.
DEVICEManual bone marrow sampling device
Hollow needle with a t-shaped handle that is pushed into the bone for the purpose of collecting bone marrow aspiration and core biopsy samples.
Sponsors
Vidacare Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults over the age of 18 * Patients that require core biopsy alone, or core biopsy and bone marrow aspiration
Exclusion criteria
* Imprisoned * Pregnant * Cognitively impaired * Requiring english language translation other than Spanish * Patients with one or more conditions precluding bone marrow core biopsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Reported Level of Pain During Procedure | Day 1 during the needle insertion | Subjects were asked to rate the level of pain they experienced during the procedure for needle insertion, following penetration of the cortex. A 0 to 10 pain scale was used where 0=no pain and 10= worst possible pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Necessary to Perform the Bone Marrow Procedure | Day 1 needle insertion through needle removal | The time necessary to perform the procedure was measured as follows: Time started once the needle and skin came into contact and time stopped once the sample was collected and the needle was removed from the patient. |
Countries
Spain, United States
Participant flow
Recruitment details
Adult patients 18 years of age requiring bone marrow aspiration and biopsy as part of routine care were considered eligible for the study.
Pre-assignment details
No pre-assisgnment details.
Participants by arm
| Arm | Count |
|---|---|
| Manual Bone Marrow Sampling Device Hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection. | 26 |
| OnControl Bone Marrow System Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest. | 24 |
| Total | 50 |
Baseline characteristics
| Characteristic | Manual Bone Marrow Sampling Device | OnControl Bone Marrow System | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 6 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 18 Participants | 34 Participants |
| Age, Continuous | 59 years STANDARD_DEVIATION 17 | 53 years STANDARD_DEVIATION 19 | 56.0 years STANDARD_DEVIATION 18 |
| Region of Enrollment Spain | 14 participants | 6 participants | 20 participants |
| Region of Enrollment United States | 12 participants | 18 participants | 30 participants |
| Sex: Female, Male Female | 12 Participants | 9 Participants | 21 Participants |
| Sex: Female, Male Male | 14 Participants | 15 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 0 / 24 |
| serious Total, serious adverse events | 0 / 26 | 0 / 24 |
Outcome results
Primary
Subject Reported Level of Pain During Procedure
Subjects were asked to rate the level of pain they experienced during the procedure for needle insertion, following penetration of the cortex. A 0 to 10 pain scale was used where 0=no pain and 10= worst possible pain.
Time frame: Day 1 during the needle insertion
Population: as per protocol, 50 patients were enrolled in the study and randomized to the manual bone marrow sampling device or the battery powered device.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual bone marrow sampling device | Subject Reported Level of Pain During Procedure | 3.8 units on a scale | Standard Deviation 3 |
| OnControl Bone Marrow System | Subject Reported Level of Pain During Procedure | 3.2 units on a scale | Standard Deviation 2.2 |
Secondary
Time Necessary to Perform the Bone Marrow Procedure
The time necessary to perform the procedure was measured as follows: Time started once the needle and skin came into contact and time stopped once the sample was collected and the needle was removed from the patient.
Time frame: Day 1 needle insertion through needle removal
Population: Per protocol, 50 patients were enrolled in the study and randomized to the manual bone marrow sampling device or the battery powered device.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual bone marrow sampling device | Time Necessary to Perform the Bone Marrow Procedure | 224.1 seconds | Standard Deviation 79 |
| OnControl Bone Marrow System | Time Necessary to Perform the Bone Marrow Procedure | 100.0 seconds | Standard Deviation 72.8 |