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

Not Applicable

Completed

• Conditions: Bone Marrow Biopsy Procedures
• Interventions: Device: Manual bone marrow sampling device; Device: OnControl Bone Marrow Biopsy and Aspiration System

• Registration Number: NCT01312519
• Lead Sponsor: Vidacare Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-07
• Study Completion: 2010-08
• Study First Submitted: 2010-11-03
• Study First Submitted QC: 2011-03-08
• Study First Posted: 2011-03-10
• Results First Submitted: 2013-02-28
• Results First Submitted QC: 2013-06-19
• Status Verified: 2013-07
• Results First Posted: 2013-07-23
• Last Update Submitted: 2013-07-29
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual bone marrow sampling device	Manual bone marrow sampling device	Hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection. Manual Bone Marrow Sampling Device.
OnControl Bone Marrow System	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. OnControl Bone Marrow Biopsy and Aspiration System.

Primary Outcome Measures

Name	Time	Method
Subject Reported Level of Pain During Procedure	Day 1 during the needle insertion	Subjects were asked to rate the level of pain they experienced during the procedure for needle insertion, following penetration of the cortex. A 0 to 10 pain scale was used where 0=no pain and 10= worst possible pain.

Secondary Outcome Measures

Name	Time	Method
Time Necessary to Perform the Bone Marrow Procedure	Day 1 needle insertion through needle removal	The time necessary to perform the procedure was measured as follows: Time started once the needle and skin came into contact and time stopped once the sample was collected and the needle was removed from the patient.

Trial Locations

Locations (2)

Cancer Therapy and Research Center; 🇺🇸 San Antonio, Texas, United States

Hospital General Universitario Gregorio Maranon; 🇪🇸 Madrid, Spain