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

July 29, 2013 updated by: Vidacare Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • Cancer Therapy and Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
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.
Other Names:
  • Jamshidi
  • Manual biopsy needle
ACTIVE_COMPARATOR: OnControl Bone Marrow 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.
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.
Other Names:
  • OnControl
  • Powered Biopsy Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject Reported Level of Pain During Procedure
Time Frame: 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.
Day 1 during the needle insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Necessary to Perform the Bone Marrow Procedure
Time Frame: 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.
Day 1 needle insertion through needle removal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vidacare Corporation

Investigators

  • Study Director: Thomas Philbeck, PhD, Vidacare Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

November 3, 2010

First Submitted That Met QC Criteria

March 8, 2011

First Posted (ESTIMATE)

March 10, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 7, 2013

Last Update Submitted That Met QC Criteria

July 29, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2007-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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