NCT01312519

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

A Trial of the Vidacare Powered Bone Marrow Aspiration and Core Biopsy Systems (OnControl by Vidacare) Compared to Traditional Manual Devices

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Vidacare Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bone Marrow Biopsy Procedures

Interventions

Type	Name	Description
DEVICE	OnControl Bone Marrow Biopsy and Aspiration System	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.
DEVICE	Manual bone marrow sampling 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.

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-07-01
• Completion: 2010-08-01
• First posted: 2011-03-10
• Last updated: 2025-12-24
• Results posted: 2013-07-23

Locations

2 sites across 2 countries: United States, Spain