N/A
Completed N=50
Powered Bone Marrow Aspiration and Core Biopsy System Compared to Manual Devices
Bone Marrow Biopsy Procedures
Source: ClinicalTrials.gov NCT01312519 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcomePrimary: Subject Reported Level of Pain During Procedure — 3.8; 3.2 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject Reported Level of Pain During Procedure |
3.8; 3.2 | — |
| SECONDARY Time Necessary to Perform the Bone Marrow Procedure |
224.1; 100.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01312519). 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. Informational only — not medical advice.