N/A
N=15
Comparing Powered Ported Bone Marrow Aspiration to Manual Standard Bone Marrow Aspiration Procedures
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02299102 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Quality of Aspirate Specimen Yield Total Score -Jamshidi Manual Standard Device — 4.83; 5.75; 1.5; 1.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Jamshidi Manual Standard Device (Device); OnControl Powered Ported Device (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Vidacare Corporation
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Aspirate Specimen Yield Total Score -Jamshidi Manual Standard Device |
4.83; 5.75; 1.5; 1.5; 1.0; 2.25 | — |
| PRIMARY Quality of Aspirate Specimen Yield Total Score -OnControl Power Ported Device |
6.29; 6.25; 1.43; 1.75; 2.57; 2.25 | — |
| SECONDARY Level of Pain With Needle Insertion- Jamshidi Manual Standard Device |
2.6; 2.57 | — |
| SECONDARY Level of Pain With Needle Insertion- OnControl Power Ported Device |
2.43; 2.38 | — |
| SECONDARY Level of Pain With Aspiration - Jamshidi Manual Standard Device |
5.33; 5.25 | — |
| SECONDARY Level of Pain With Aspiration - OnControl Power Ported Device |
3.86; 4.5 | — |
| SECONDARY Time to Insertion - Jamshidi Manual Standard Device |
55.04; 79.27 | — |
| SECONDARY Time to Insertion - OnControl Power Ported Device |
32.63; 25.80 | — |
| SECONDARY Time for Aspirate Collection - Jamshidi Manual Standard Device |
75.74; 129.24 | — |
| SECONDARY Time for Aspirate Collection - OnControl Power Ported Device |
57.9; 48.33 | — |
Summary
This single center study will compare the manual standard bone marrow aspiration device to the powered ported bone marrow aspiration device for use in the iliac crest in healthy adult volunteers. The study will evaluate the subjects' perceived level of pain, time to sample acquisition, and quality of specimen yield of these devices. Each subject will receive bilateral bone marrow aspiration procedures using both the manual standard and powered ported devices.
Eligibility Criteria
Inclusion Criteria
- Adults 21 years of age and over
- Able to lay flat in prone position on a table for up to 1 hour
- Self-reported as healthy, as confirmed by the investigator during the medical history review and physical examination
- Female subjects with a negative urine pregnancy test at screening visit
Exclusion Criteria
- Reported fever within 7 days of the screening visit
- Reported active infection within 7 days of the screening visit
- Fever on day of study procedure
- Signs/symptoms of active infection on day of study procedure
- Imprisoned
- Self identified as pregnant or lactating
- Cognitively impaired
- Patients with one or more conditions precluding bone marrow aspiration
- Excessive tissue and/or absence of adequate anatomical landmarks in target bone
- Allergy to local anesthetics
- Unable to lay flat in prone position
- Prothrombin time and International Normalized Ratio (PT/INR) results outside of normal range on screening lab work and deemed clinically significant by the investigator
Data sourced from ClinicalTrials.gov (NCT02299102). 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.