N/A N=50 Randomized Diagnostic

Powered Bone Marrow Aspiration and Core Biopsy System Compared to Manual Devices

Bone Marrow Biopsy Procedures

Bottom Line

View on ClinicalTrials.gov: NCT01312519 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2013

Primary outcome: Primary: Subject Reported Level of Pain During Procedure — 3.8; 3.2 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: OnControl Bone Marrow Biopsy and Aspiration System (Device); Manual bone marrow sampling device (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vidacare Corporation
Primary completion: Jul 2010

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	—

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.

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

View full record on ClinicalTrials.gov →

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.