Comparison of a Powered Bone Marrow Biopsy Device With a Manual System

February 16, 2012 updated by: University Hospital, Basel, Switzerland

a Prospective Randomized Controlled Trial Comparing a Powered Bone Marrow Biopsy Device With a Manual System

Bone marrow biopsy quality as quantified by biopsy cylinder length and diagnostic usefulness is improved with a powered bone marrow biopsy device in comparison with a manual device.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

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

  • Switzerland
    • BS
      • Basel, BS, Switzerland, 4032
        • University Hospital Basel

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:

  • age > 18
  • >= one previous bone marrow procedure
  • INR > 1.4
  • tThrombocyte count > 10 x109/l
  • informed consent signed

Exclusion Criteria:

  • cognitive impairment
  • excessive tissue at anatomical landmarks
  • BMI > 35 kg/m2
  • allergy to premedication
  • unable to lay flat in prone position

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Manual (Hospital Systems TRAP Needle)
Bone marrow biopsy with a standard manual system
Device: OnControl BM-Biopsy system
Bone marrow biopsy at posterior iliac crest
Other Names:
  • http://www.vidacare.com/OnControl/Bone-Marrow-Clinicians.aspx
  • http://www.hsmedicalinc.com/
Experimental: Powered
Device: OnControl BM-Biopsy system
Bone marrow biopsy at posterior iliac crest
Other Names:
  • http://www.vidacare.com/OnControl/Bone-Marrow-Clinicians.aspx
  • http://www.hsmedicalinc.com/

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic usefulness (yes/no) of biopsy cylinder
Time Frame: within 1 week of biopsy
The bone marrow biopsy cylinder is assessed by a pathologist who rates either "diagnostic" or "non diagnostic"
within 1 week of biopsy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient pain during procedure
Time Frame: day 1 (two time points) and day 3-5
patients underdoing biopsy rate the pain during, 15 min after and 3-5 days after the proceedure
day 1 (two time points) and day 3-5

Collaborators and Investigators

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

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Christoph M Bucher, MD, University Hospital, Basel, Switzerland

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

May 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

February 9, 2012

First Submitted That Met QC Criteria

February 16, 2012

First Posted (Estimate)

February 17, 2012

Study Record Updates

Last Update Posted (Estimate)

February 17, 2012

Last Update Submitted That Met QC Criteria

February 16, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • Biopsycontrol

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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