N/A
N=44
A Study Comparing Use of Manual and Power Bone Marrow Aspiration and Biopsy Devices in Children
Bone Marrow Aspiration and Biopsy Specimen Collection
Bottom Line
View on ClinicalTrials.gov: NCT02159118 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Percent of Hematopoietic Tissue Present in Bone Marrow Biopsy Specimens Obtained Using the Manual Device and Powered Device — 42.5; 55.8 % Hematopoetic tissue present — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Manual bone marrow aspiration and biopsy device (Device); Powered bone marrow aspiration and biopsy device (Device)
- Age
- Pediatric, Adult · 2+ yrs
- Sex
- All
- Sponsor
- Vidacare Corporation
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Hematopoietic Tissue Present in Bone Marrow Biopsy Specimens Obtained Using the Manual Device and Powered Device |
42.5; 55.8 | 0.03 sig |
| SECONDARY Bone Marrow Biopsy Specimen Size (Length) Obtained Using the Manual Device and the Powered Device |
13.9; 13.4 | 0.65 |
| SECONDARY Bone Marrow Biopsy Specimen Size (Width) Obtained Using the Manual Device and the Powered Device |
1.4; 1.8 | <0.001 sig |
| SECONDARY Bone Marrow Biopsy Specimen Size (Volume) Obtained Using the Manual Device and the Powered Device |
23.8; 36.5 | 0.01 sig |
| SECONDARY Bone Marrow Biopsy Specimen Capture Rate for the Manual Device and the Powered Device |
1.1; 1.4 | 0.06 |
| SECONDARY Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Aspiration Specimen Acquisition Using the Manual Device and the Powered Device |
55; 53.2 | 0.93 |
| SECONDARY Patient Level of Post-procedural Pain Following Use of the Manual Device and the Powered Device |
0.27; 0.68 | 0.22 |
| SECONDARY Operator Satisfaction With Manual Device and Powered Device |
9; 9.2 | 0.51 |
| SECONDARY 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; 224.5 | 0.08 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02159118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.