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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01535313
First received: February 9, 2012
Last updated: February 16, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Bone Marrow Biopsy
Device: OnControl BM-Biopsy system

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: a Prospective Randomized Controlled Trial Comparing a Powered Bone Marrow Biopsy Device With a Manual System

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Diagnostic usefulness (yes/no) of biopsy cylinder [ Time Frame: within 1 week of biopsy ] [ Designated as safety issue: No ]
    The bone marrow biopsy cylinder is assessed by a pathologist who rates either "diagnostic" or "non diagnostic"


Secondary Outcome Measures:
  • patient pain during procedure [ Time Frame: day 1 (two time points) and day 3-5 ] [ Designated as safety issue: No ]
    patients underdoing biopsy rate the pain during, 15 min after and 3-5 days after the proceedure


Enrollment: 60
Study Start Date: May 2011
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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/

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01535313

Locations
Switzerland
University Hospital Basel
Basel, BS, Switzerland, 4032
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Christoph M Bucher, MD University Hospital, Basel, Switzerland
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01535313     History of Changes
Other Study ID Numbers: Biopsycontrol
Study First Received: February 9, 2012
Last Updated: February 16, 2012
Health Authority: Switzerland: Ethikkommission

ClinicalTrials.gov processed this record on September 18, 2014