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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual bone marrow sampling device | Active Comparator | Hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection. Manual Bone Marrow Sampling Device. |
|
| OnControl Bone Marrow System | Active Comparator | Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest. OnControl Bone Marrow Biopsy and Aspiration System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OnControl Bone Marrow Biopsy and Aspiration System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 during the needle insertion |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 needle insertion through needle removal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Philbeck, PhD | Vidacare Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Therapy and Research Center | San Antonio | Texas | 78229 | United States | ||
| Hospital General Universitario Gregorio Maranon |
No pre-assisgnment details.
Adult patients 18 years of age requiring bone marrow aspiration and biopsy as part of routine care were considered eligible for the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | OnControl Bone Marrow System | Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | OnControl Bone Marrow System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | as per protocol, 50 patients were enrolled in the study and randomized to the manual bone marrow sampling device or the battery powered device. | Posted | Mean | Standard Deviation | units on a scale | Day 1 during the needle insertion |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director of Science and Clinical | Vidacare Corporation | 210-375-8500 | thomas.philbeck@vidacare.com |
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|
| Manual bone marrow sampling device | 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. |
|
|
| Madrid |
| 28007 |
| Spain |
Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest. |
|
|
| 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. | Per protocol, 50 patients were enrolled in the study and randomized to the manual bone marrow sampling device or the battery powered device. | Posted | Mean | Standard Deviation | seconds | Day 1 needle insertion through needle removal |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | OnControl Bone Marrow System | Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest. | 0 | 24 | 0 | 24 |
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