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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01535313
First Posted: February 17, 2012
Last Update Posted: February 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: a Prospective Randomized Controlled Trial Comparing a Powered Bone Marrow Biopsy Device With a Manual System

Resource links provided by NLM:


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 ]
    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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01535313     History of Changes
Other Study ID Numbers: Biopsycontrol
First Submitted: February 9, 2012
First Posted: February 17, 2012
Last Update Posted: February 17, 2012
Last Verified: February 2012