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

Bone Marrow Biopsy Procedures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01312519
• Other study ID #: 2007-04
• Status: Completed
• Phase: N/A
• First received: November 3, 2010
• Last updated: July 29, 2013
• Start date: January 2010
• Est. completion date: August 2010

Study information

• Verified date: July 2013
• Source: Vidacare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardSpain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bone Marrow Biopsy Procedures

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital General Universitario Gregorio Maranon	Madrid
United States	Cancer Therapy and Research Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Vidacare Corporation

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject Reported Level of Pain During Procedure	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.	Day 1 during the needle insertion	No
Secondary	Time Necessary to Perform the Bone Marrow Procedure	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.	Day 1 needle insertion through needle removal	No